To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices.
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
27pct
1d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices. Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation. To expedite the development and review of designated medical devices, the FDA must: assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.
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Filing registrants (2)
2016 · fourth_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Oppose Section 2 of HR 2337 Support a stronger US position at the UN General Assembly on the World Drug Problem on: acknowledging the ramifications of new drug policies; standing up for human rights; calling for a people-centered approach to drug policy; taking a stronger stance on criminal justice reform; and ensuring an open dialog between all interested parties. Support President Obama speaking at the UNGASS on the world drug problem. Support Sec. Burwell speaking at UNGASS Support H Res 780
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2016 · third_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Oppose Section 2 of HR 2337 Support a stronger US position at the UN General Assembly on the World Drug Problem on: acknowledging the ramifications of new drug policies; standing up for human rights; calling for a people-centered approach to drug policy; taking a stronger stance on criminal justice reform; and ensuring an open dialog between all interested parties. Support President Obama speaking at the UNGASS on the world drug problem. Support Sec. Burwell speaking at UNGASS
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2016 · third_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Oppose Section 2 of HR 2337 Support a stronger US position at the UN General Assembly on the World Drug Problem on: acknowledging the ramifications of new drug policies; standing up for human rights; calling for a people-centered approach to drug policy; taking a stronger stance on criminal justice reform; and ensuring an open dialog between all interested parties. Support President Obama speaking at the UNGASS on the world drug problem. Support Sec. Burwell speaking at UNGASS
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2016 · second_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Oppose Section 2 of HR 2337 Support a stronger US position at the UN General Assembly on the World Drug Problem on: acknowledging the ramifications of new drug policies; standing up for human rights; calling for a people-centered approach to drug policy; taking a stronger stance on criminal justice reform; and ensuring an open dialog between all interested parties. Support President Obama speaking at the UNGASS on the world drug problem. Support Sec. Burwell speaking at UNGASS
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2016 · second_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)
Client expense: $15,681 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)
2016 · first_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Oppose Section 2 of HR 2337 Support a stronger US position at the UN General Assembly on the World Drug Problem on: acknowledging the ramifications of new drug policies; standing up for human rights; calling for a people-centered approach to drug policy; taking a stronger stance on criminal justice reform; and ensuring an open dialog between all interested parties. Support President Obama speaking at the UNGASS on the world drug problem. Support Sec. Burwell speaking at UNGASS
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2015 · fourth_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731 Rare Disease Fund Act of 2015 (Andrew Los brainchild) HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology)
Client expense: $58,549 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Foreign Relations
Support H.R. 735 Support President Obama's initiatives towards Cuba Support debt relief for the globe's poorest nations Support the creation of an aggressive, developed in conjunction with the African Union, to bring peace and stability to Sudan. Support the United States to accept Universal Periodic Review (UPR) Recommendations 176.88 and 176.108 and declare its intention to implement these recommendations with a new Executive Order focused on the ongoing domestic implementation of its human rights obligations. In support of greater ambition and to provide points that our network knows are necessary for a strong outcome in Paris at the COP21 summit. Oppose Section 2 of HR 2337
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2015 · fourth_quarter · Immigration
Support restoring DACA/DAPA eligibility for the Affordable Care Acts affordability credits. Oppose H.R. 399 Oppose HR 240 Support HR 1974 Oppose federal Prosecutions for Illegal Entry (8 U.S.C. 1325) and Illegal Re-entry (8 U.S.C. 1326) Oppose a new five-year mandatory minimum sentence for illegal reentry. Support HR 3201 Oppose the potential deportation of Shellion Parris and other workers at Mr. Clean, in Florida Oppose Section 2 of HR 2337 Oppose anti-Muslim, Islamophobic rhetoric, actions, and legislation.
Client expense: $68,750 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Alcohol Tobacco Firearms & Explosives, Bureau of Prisons (BOP), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Defense, Dept of (DOD), Education, Dept of, Election Assistance Commission (EAC), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Credit Union Administration (NCUA), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Office of Faith-Based & Community Initiatives, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office
2015 · third_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research
Client expense: $58,549 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Health Issues
S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax)
Client expense: $29,766 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Immigration
S 153 I-Squared Act of 2015 S 341 Start-up Jobs and Innovation Act HR 962 Startup Act HR 213 Fairness for High-Skilled Immigrants Act of 2015 Health (Bill) S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax)
Client expense: $29,766 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $36,139 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE