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HR 887 117th Congress House Health Business records Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies

DEVICE Act of 2021

Introduced: February 5, 2021 Introduced by: Lieu, Ted Democratic · California See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 8, 2021
Referred to the Subcommittee on Health.
Feb 5, 2021
Referred to the House Committee on Energy and Commerce.
Feb 5, 2021
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now February 8, 2021

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Democratic 2