H.R. 4965 · 114th Congress
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
LieuSponsor6 cosponsors · 6 D
0 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 2016
What it does: CRS summary · Introduced in House · Apr 15, 2016
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016
This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device.
Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device.
The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers.
The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016
Latest action (Apr 22, 2016): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 15, 2016
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.