US Food and Drug Administration (2024)
U.S. Food and Drug Administration.
URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
Abstract. Final
FDA guidance establishing the framework for predetermined change control plans (PCCPs), allowing manufacturers of
AI/ML-enabled devices to specify anticipated modifications in advance and implement changes within pre-approved boundaries without additional regulatory submissions.