To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Agriculture, Transportation.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section S1: 1. Short title This Act may be cited as the Medical Device Recall Improvement Act.
- Section id7f50b1c0d98749e3901f7024fad68451: 2. Regulation of medical device recalls Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), is amended by inserting after section...
- Section id303dc41eb575402786185e3c36314079: 518B. Electronic notification format for device recalls Not later than 2 years after the date of enactment of the Medical Device Recall Improvement Act, the...
- Section idF183F4367ED740E0BB5C43D52A0093D7: 518C. Patient notification The Secretary shall require that any recall strategy under section 519(g) provides for notice to patients whom device user...
- Section idf845e55c31024b93bd7757b603f36a6a: 3. Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following (jjj)The refusal or...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This bill, To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Agriculture, Transportation
Primary Purpose
This bill, To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Legislative Progress
IntroducedMr. Durbin introduced the following bill; which was read twice …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → The Secretary identified in the operative section
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
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