H.R. 887 · 117th Congress
DEVICE Act of 2021
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
LieuSponsor2 cosponsors · 2 D
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021
What it does: CRS summary · Introduced in House · Feb 5, 2021
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021
This bill addresses design changes and reprocessing of medical devices.
Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.)
A device may not be sold if the manufacturer violates these notification requirements.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: DEVICE Act of 2021
Also known as: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021
Latest action (Feb 8, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Feb 5, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.