Fostering Innovation in Medical Imaging Act of 2017

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

Client expense: Not reported · Firm income: $80,000

Government targets: Bureau of Land Management (BLM), HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

Client expense: Not reported · Firm income: $70,000

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

Client expense: Not reported · Firm income: $70,000

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

Client expense: Not reported · Firm income: $70,000

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017. H. R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes. H. R. 1892, the Bipartisan Budget Act of 2018. H. R. 1625, the Consolidated Appropriations Act of 2018.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA)

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $520,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $510,000 · Firm income: Not reported

Government targets: Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administration action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.

Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

Client expense: Not reported · Firm income: $70,000

S. 108 - Medical Device Access and Innovation Protection Act H.R. 184 - Protect Medical Innovation Act of 2017 H.R. 1628 - American Health Care Act of 2017 Business tax reform VA medical equipment acquisition Medical imaging reimbursement Energy and Water Development Appropriations S. 934 - FDA Reauthorization Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 2118 - Medical Device Servicing Safety and Accountability Act H.R. 2009 - Fostering Innovation in Medical Imaging Act of 2017 H.R. 2479 - Protecting Business Opportunities for Veterans Act

Client expense: $1,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administration action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3921, HEALTHY KIDS Act.

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

Client expense: Not reported · Firm income: $70,000

Issues related to the repeal of the medical device excise tax including S.108, the Medical Device Access and Innovation Protection Act and H. R. 184, the Protect Medical Innovation Act of 2017. S.Con.Res. 3, the concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. House and Senate efforts to repeal and replace the Affordable Care Act including amendments to the H. R. 1628, the Affordable Health Care Act of 2017, including versions of the Better Care Reconciliation Act as well as the Graham-Cassidy proposal, and provisions to repeal the medical device tax. Issues related to H. R. 2430, The FDA Reauthorization Act (FDARA) of 2017. Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

Client expense: Not reported · Firm income: $80,000

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $520,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act.

Issues related to the repeal of the medical device excise tax including S.108, the Medical Device Access and Innovation Protection Act and H. R. 184, the Protect Medical Innovation Act of 2017. S.Con.Res. 3, the concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. Provisions included in H. R. 1628, the American Health Care Act of 2017, the Better Care Reconciliation Act of 2017 to repeal the medical device excise tax. Issues related to H. R. 2430, The FDA Reauthorization Act (FDARA) of 2017. Issues related to service of medical devices. Issues related to the regulation of contrast agents and medical imaging indications. Issues related to cybersecurity related to medical devices. Issues related to H. R. 2118, the Medical Device Servicing Safety and Accountability Act. Issues related to H. R. 2009, the Fostering Innovation in Medical Imaging Act of 2017.

Client expense: Not reported · Firm income: $80,000

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 1736, aims to improve FDA's process for inspecting medical device manufacturing facilities and granting export certificates. H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents. H.R. 1652, would require FDA to issue regulations for over-the-counter hearing aids H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710). S. 1070, which reflects the accessories language that's included in the manager's amendment (Section 709) ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment

Client expense: Not reported · Firm income: $70,000

LAB Developed Tests H.R. 2009 Medical Device User Fee Reauthorization H.R. 1628, AHCA

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

MDUFA Reauthorization; H.R. 2009; H.R. 2118; Medical Device Tax

Client expense: $510,000 · Firm income: Not reported

Government targets: Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Energy, Dept of, HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

LAB Developed Tests H.R. 2009 Medical Device User Fee Reauthorization H.R. 1628, AHCA

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to womens health issues. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents.

Client expense: $2,450,000 · Firm income: Not reported