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H.R. 872 (115th): DEVICE Act of 2017

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on 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.