US Congress House Bill 872 (Prior Session Legislation)

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Spectrum: Partisan Bill (Democrat 7-0)
Status: Introduced on February 6 2017 - 25% progression, died in committee
Action: 2017-02-10 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

DEVICE Act of 2017 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency 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.

DEVICE Act of 2017 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017

Rep. Ted Lieu [D-CA]	Rep. Judy Chu [D-CA]	Rep. Elijah Cummings [D-MD]	Rep. Eleanor Norton [D-DC]
Rep. Gwen Moore [D-WI]	Rep. Louise Slaughter [D-NY]	Rep. Raul Grijalva [D-AZ]

Date	Chamber	Action
2017-02-10	House	Referred to the Subcommittee on Health.
2017-02-06	House	Referred to the House Committee on Energy and Commerce.
2017-02-06	House	Introduced in House

Type	Source
Summary	https://www.congress.gov/bill/115th-congress/house-bill/872/all-info
Text	https://www.congress.gov/115/bills/hr872/BILLS-115hr872ih.pdf