DEVICE Act of 2021
Official title: To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.
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Referred to the Subcommittee on Health.
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.
- Introduced in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 887: DEVICE Act of 2021. 117th Congress. Open America. https://openamerica.io/bill/117-HR-887/
"H.R. 887: DEVICE Act of 2021." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-887/.
H.R. 887, 117th Cong. (2026), https://openamerica.io/bill/117-HR-887/.
[H.R. 887: DEVICE Act of 2021](https://openamerica.io/bill/117-HR-887/)