Rules / United States (federal)

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

In forceGuidelineNon-binding

Final FDA guidance explaining how makers of AI-enabled medical devices can include a Predetermined Change Control Plan in 510(k), De Novo or PMA submissions describing planned model modifications, the protocol for developing and validating them, and an impact assessment. Changes made within an authorised PCCP do not need a new marketing submission.

Why it matters

Medical-AI companies can pre-clear model retraining and performance updates rather than filing a new submission for each change.

What it requires

Impact assessmentData governanceTransparency to users
SourceU.S. Food and Drug Administration: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligenceSecondary: https://www.federalregister.gov/documents/2024/12/04/2024-28361/marketing-submission-recommendations-for-a-predetermined-change-control-plan-for-artificial Checked against the source on 4 Oct 2026. FDA's guidance page now shows the final guidance dated August 2025 (updated version). The broader 'AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations' guidance (Jan 2025) is still listed as draft. FDA's AI-enabled device list contained 1,614 devices (decisions through 29 Jun 2026).

Cite this record

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. U.S. Food and Drug Administration (CDRH, CBER, CDER). Status: In force. wheresthe.ai, https://wheresthe.ai/rule/us-fda-pccp-ai-device-guidance/ (verified 4 Oct 2026).

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