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Congress Gets FDA Goals for Device Makers After Stalled Talks (1)

March 9, 2022, 3:25 PM

The FDA has sent to Congress its five-year goals for the medical device industry, nearly two months after the deadline lapsed, according to a source familiar with the exchange. The letter isn’t public.

Transmission of the initial commitment letter marks the latest step in the congressional review process for the next round of user fee agreements between the Food and Drug Administration and the drug and device industries. The deals, including the Medical Device User Fee Amendments, are considered must-pass legislation and govern the fees that industry pays to the agency, which make up nearly half of the FDA’s budget. ...