Proposal:DEVICE Act of 2021

This proposal is archived and closed to further debate. It was introduced in the 117th Congress, which has concluded, and the bill was not enacted into law.

Bill	HR 887
Type of Legislation	House Bill
Congress	117
Status	Archived — 117th Congress concluded
Source	View original on Congress.gov

Geographic Scope

National

Description

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.

Bill Title

DEVICE Act of 2021

Linked Goals

• Goal:Promote General Welfare

Steps

Steps taken on this bill were not available from Congress.gov.

Projected Outcome

A more informed proposal or public response aligned with the Promote General Welfare goal.