H.R. 818 · 116th Congress
DEVICE Act of 2019
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
LieuSponsor4 cosponsors · 4 D
4 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 2019 or the DEVICE Act of 2019
What it does: CRS summary · Introduced in House · Jan 28, 2019
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019
This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (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. A device may not be sold if the manufacturer violates these notification requirements.
Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: DEVICE Act of 2019
Also known as: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019
Latest action (Jan 29, 2019): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jan 28, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.