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Realizing Intended Safety for Certain Accessories Act of 2017
Legislative Progress
Momentum (last 30 days)
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vs 3,805 other S bills in the 115th — cohort avg 41d
Risk-Based Classification of Accessories Act of 2017 This bill revises how accessories to medical devices are classified. Specifically, the Food and Drug Administration must classify accessories based on the risks when used as intended , notwithstanding the classification of any other device with which such accessory is intended to be used.
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)
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
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: $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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · third_quarter · Health Issues
Issues related to post-market surveillance of medical devices and unique device identifiers. Reauthorization of the medical device user fee agreement (H.R. 2430/S. 934, FDA Reauthorization Act of 2017), including policy issues related to FDA inspections reform (S. 404, H.R. 1736), 510(k) process (H.R. 2474, Medical Product Review Harmonization Act of 2017), and accessories (H.R. 2144, Risk-Based Classification of Accessories Act of 2017; S. 1070, Realizing Intended Safety for Certain Accessories Act of 2017.
Client expense: $440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
2017 · second_quarter · Health Issues
Issues related to post-market surveillance of medical devices and unique device identifiers. Reauthorization of the medical device user fee agreement (H.R. 2430/S. 934, FDA Reauthorization Act of 2017), including policy issues related to FDA inspections reform (S. 404, H.R. 1736), 510(k) process (H.R. 2474, Medical Product Review Harmonization Act of 2017), and accessories (H.R. 2144, Risk-Based Classification of Accessories Act of 2017; S. 1070, Realizing Intended Safety for Certain Accessories Act of 2017.
Client expense: $560,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
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