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Medical Device Safety Monitoring Act
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
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vs 3,805 other S bills in the 115th — cohort avg 41d
Medical Device Safety Monitoring Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to support pilot projects in order to provide timely and reliable information on the safety and effectiveness of marketed medical devices. The projects must: (1) be designed to generate safety and active surveillance data, (2) inform support for safety and active surveillance activities, (3) be coordinated with a system for evaluating medical device technology that operates under a board with representation from consumer groups and device manufacturers, and (4) use electronic health data. The FDA may determine that a manufacturer's participation in a pilot project satisfies requirements regarding reporting or postmarket surveillance if the project captures adverse event information and the FDA has established procedures to publish safety information from the project. Not later than January 31, 2021, the FDA must evaluate real world evidence pilot projects, such as the ones supported by this bill, for their ability to inform decision-making and efficiently generate evidence about the safety or effectiveness of medical devices.
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 (2)
2018 · fourth_quarter · Health Issues
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
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
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · second_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · first_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · fourth_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · third_quarter · Health Issues
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
2017 · 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 regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to implementation of 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 H.R. 2430 and S. "934" The FDA Reauthorization Act H.R. 2474 Medical Product Review Harmonization Act H.R. 2144 and SS. 1070 related to the classification of medical device accessories H.R. 2483 and S. 1183 related to modifications to medical devices S. 1069 related to postmarket regulation of medical devices H.RR. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications S.404 and H.R. 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications Issues related to diagnostics regulation Issues related to diagnostics payment reform 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 procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies Issues related to federal regulation of the distribution and supply chain for medical devices
2017 · 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 regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to implementation of 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 H.R. 2430 and S. 934 The FDA Reauthorization Act H.R. 2474 Medical Product Review Harmonization Act H.R. 2144 and SS. 1070 related to the classification of medical device accessories H.R. 2483 and S. 1183 related to modifications to medical devices S. 1069 related to postmarket regulation of medical devices H.RR. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications S.404 and H.R. 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications Issues related to diagnostics regulation Issues related to diagnostics payment reform 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 procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues related to AHCA/BCRA
Client expense: $760,000 · Firm income: Not reported
2017 · second_quarter · Health Issues
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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