FDA Ends Pre-Cert But Could Revisit In The Future, With Congress’ Help

By Kelly Lienhard / May 31, 2022 at 5:19 PM
FDA recently decided to end its device software precertification pilot program and hand development over to the Medical Device Innovation Consortium, saying it needs additional authority from Congress to implement the program as envisioned, but it may not be the end of the road for the initiative. One former FDA official believes the agency may eventually try to revisit the pre-cert program, though he acknowledged it could take years, especially as Congress would need to sign off. “Congress can actually...

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