FDA Guidance
Predetermined Change Control Plans (PCCP) for AI/ML Medical Devices: An Interpretive Guide
**Summary:** The FDA's December 2024 PCCP guidance allows AI/ML medical device makers to pre-approve post-market algorithm changes without new submissions, provided they submit detailed plans describing anticipated modifications, implementation methods, and performance standards. Common deficiencies include vague change descriptions, inadequate performance metrics, and insufficient risk documentation.