H.R. 872 · 115th Congress
DEVICE Act of 2017
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
LieuSponsor6 cosponsors · 6 D
5 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 2017 or the DEVICE Act of 2017
What it does: CRS summary · Introduced in House · Feb 6, 2017
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 or the DEVICE Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to 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 2017
Also known as: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017
Latest action (Feb 10, 2017): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Feb 6, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.