Summary
Final guidance describing how to include a Predetermined Change Control Plan in marketing submissions for AI‑enabled device software functions. Explains PCCP components (Description of Modifications, Modification Protocol, Impact Assessment) and U.S. Food and Drug Administration's review expectations.
Healthcare Implications
Enables post‑market, pre‑authorized model updates without new submissions when within an approved Predetermined Change Control Plan – accelerating safe iteration of AI‑enabled devices. Hospitals and clinicians can expect timelier performance improvements with clearer labeling and change controls.