MICHAEL MATTOON

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

S.758, A bill to establish a Science, Technology, Engineering, and Math (STEM) Master Teacher Corps program S.716, Innovation Inspiration School Grant Program Act- to promote STEM education H.R. 3373- STEM Education Innovation Act- to promote STEM education

S. 758, A bill to establish a Science, Technology, Engineering and Math (STEM) Master Teacher Corps program S. 716, Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 3373 - STEM Education innovation Act - to promote STEM education H.R. 6517 - The STEM Network Act - to promote STEM education

S. 758, A bill to establish a Science, Technology, Engineering, and Math (STEM) Master Teacher Corps program S. 716, Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 3373 - STEM Education Innovation Act - to promote STEM education H.R. 6517 - The STEM Network Act - to promote STEM education

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

S. 17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R.488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S.239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of hte alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform

S.17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R.488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S.239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of hte alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S. 17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination H.R. 5651 - Food and Drug Administration Reform Act 2012 - A bill to renew the FDA User Fee program and to reform the medical device review program. S. 3187 - FDA Safety and Innovation Act - A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Senate draft legislation to establish a national track and trace system for pharmaceuticals, specifically relating to convenience kits

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Appropriations for the Food and Drug Administration, particularly the Center for Devices and Radiological Health Appropriations for pain management awareness programs HR5973 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 S. 2375 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013

Appropriations for pain management awareness programs H.R. 5973 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 S. 2375 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 H.J. Res. 117 - Continuing Appropriations Act - provisions related to user fees for FDA

Appropriations for the Food and Drug Administration, particularly the Center for Devices and Radiological Health Appropriations for pain management awareness programs H.R. 5973 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 S. 2375 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 H.J. Res. 117 - Continuing Appropriations Act - provisions related to user fees for FDA

S. 758, A bill to establish a Science, Technology, Engineering and Math (STEM) Master Teacher Corps program S. 716, Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 3373 - STEM Education innovation Act - to promote STEM education H.R. 6517 - The STEM Network Act - to promote STEM education

S. 758, A bill to establish a Science, Technology, Engineering, and Math (STEM) Master Teacher Corps program S. 716, Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 3373 - STEM Education Innovation Act - to promote STEM education H.R. 6517 - The STEM Network Act - to promote STEM education

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S. 17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R.488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S.239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of hte alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform

S.17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R.488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S.239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of hte alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S. 17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.