The Vitals

Dems' Bill Mandates Device Makers Tell FDA If Reprocessing Protocols Shift

February 10, 2017
Six House Democrats have introduced a bill that requires device manufacturers to notify FDA of post-market device design and reprocessing changes before making such changes, and says manufacturers or their affiliates must notify FDA of certain communications they have with regards to reprocessing, including communications with foreign health care providers. The bill also defines a medical device as a rapid assessment test to ensure proper reprocessing and refines the reusable device definition. The bill, H.R. 872, is sponsored by Rep...

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