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 H3C8141672E354AC48405630F9501C359: 1. Short title This Act may be cited as the Medical Device Recall Improvement Act.
- Section H7B73AEE6DD9F4D3A96FA89A0D00B8BC2: 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 H31E2A3282DBB40EB8A9F5AC122BAA3A2: 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 HCFE9BA132EE24C9DAC73283F6ED823E9: 518C. Patient notification The Secretary shall require that any recall strategy under section 519(g) provides for notice to patients whom device user...
- Section HB20B2F21B36A4D92B316D31122589F23: 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
IntroducedMs. Schakowsky introduced the following bill; which was referred to …
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.
Learn more about our methodology