Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
The FDA Law Blog
FEBRUARY 13, 2025
Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Details of the PCCP will be publicly available (i.e., PMA summary of safety and effectiveness document (SEED) and approval order, 510(k) Summary, De Novo decision summary).
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