H.R.872 - DEVICE Act of 2017115th Congress (2017-2018)
|Sponsor:||Rep. Lieu, Ted [D-CA-33] (Introduced 02/06/2017)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 02/10/2017 Referred to the Subcommittee on Health. (All Actions)|
This bill has the status Introduced
Here are the steps for Status of Legislation:
Summary: H.R.872 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in House (02/06/2017)
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.