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Improving Medical Device Innovation Act
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vs 3,548 other S bills in the 114th — cohort avg 43d
Improving Medical Device Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels. A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales.) The FDA must: train employees who review premarket submissions for medical devices on recognized standards; review its published principles for recognizing standards; identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness; ensure that adequate expertise is represented on medical device classification panels; provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels. The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (7)
2016 · fourth_quarter · Health Issues
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
H.R. 34, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures H.R. 3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 Innovation For Healthier Americans H.R. 34 - 21st Century Cures Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1101 - MEDTECH Act S. 1622 - FDA Device Accountability Act of 2015 S. 2737 - Improving Medical Device Innovation Act
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. H.R. 34 - 21st Century Cures Act - provisions related to medical innovation, technology and medical devices. S. 3504 - Chronic Care Act of 2017 - provisions related to teleheath and diabetes. S. 2873 - Echo Act - provisions related to telehealth. H.R. 2020 - Short Term Continuing Resolution - provisions related to federal funding of the government through April 28, 2017. Issues related to VA procurement and devices.
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to the regulation of blood glucose meters HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to FDA inspection of foreign and domestic manufacturing facilities Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act
2016 · third_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B
Client expense: Not reported · Firm income: Not reported
2016 · third_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B
Client expense: Not reported · Firm income: Not reported
2016 · third_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. H.R. 4155/S.2343 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 524 - Comprehensive Addiction and Recovery Act of 2016 - provisions related to pain management. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. S. Res. 438 - Designating September 2016 as "National Brain Aneurysm Awareness Month." H.R. 5325 - Short-Term Continuing Resolution - provisions related to opioid funding. Issues related to VA procurement and devices.
Client expense: $940,000 · Firm income: Not reported
2016 · third_quarter · Health Issues
H.R. 6, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act
2016 · third_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 6 - 21st Century Cures H.R. 3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 Innovation For Healthier Americans ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester S. 1077 - Advancing Breakthrough Medical Devices for Patients Act S. 1101 - Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1767 - Combination Products Innovation Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 1101 - MEDTECH Act S. 1622 - FDA Device Accountability Act of 2015 S. 2737 - Improving Medical Device Innovation Act
Client expense: Not reported · Firm income: $70,000
2016 · third_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. H.R. 4155/S.2343 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 524 - Comprehensive Addiction and Recovery Act of 2016 - provisions related to pain management. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. S. Res. 438 - Designating September 2016 as "National Brain Aneurysm Awareness Month."
Client expense: $920,000 · Firm income: Not reported
2016 · second_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act
Client expense: $680,000 · Firm income: Not reported
2016 · second_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R. 6, the "21st Century Cures Act," specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the "Food and Drug Administration Safety Over Sequestration Act." H.R. 160, the"Protect Medical Innovation Act. S. 149, the "Medical Device Access and Innovation Protection Act." S. 1077, the "Advancing Breakthrough Devices for Patients Act." S. 1622, the "FDA Device Accountability Act." S. 2737, the "Improving Medical Device Innovation Act." Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R. 6, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to the regulation of contact lenses S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act
Client expense: $1,140,000 · Firm income: Not reported
2016 · first_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. Issues related to remote patient management and telehealth. H.R. 4155 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2343 - Teleheath Innovation and Improvement Act of 2015 - provisions related to remote patient management and teleheath. S. 2187- FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions relating to clarification of processes around approval and GMPs of combination products. S. 2737 - Improving Medical Device Innovation Act - provisions relating to medical device innovation.
Client expense: $1,000,000 · Firm income: Not reported
2016 · first_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. Issues related to remote patient management and telehealth. H.R. 4155 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2343 - Teleheath Innovation and Improvement Act of 2015 - provisions related to remote patient management and teleheath. S. 2187- FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions relating to clarification of processes around approval and GMPs of combination products. S. 2737 - Improving Medical Device Innovation Act - provisions relating to medical device innovation.
Client expense: $996,000 · Firm income: Not reported
2016 · first_quarter · Health Issues
H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R. 6, the "21st Century Cures Act," specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the "Advancing Breakthrough Devices for Patients Act." S. 1622, the "FDA Device Accountability Act." S. 2737, the "Improving Medical Device Innovation Act." Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE