Regulatory pathway · all topics

Predetermined Change Control Plan (PCCP)

PCCP allows planned modifications to AI/ML-enabled device software without requiring a new submission for each change. Authorized in FDA guidance 'Marketing Submission Recommendations for a Predetermined Change Control Plan' (Aug 2024). PCCP must specify the modifications, modification protocol (validation methods), and impact assessment. Common use: planned retraining of locked algorithm against new data. Sponsor reports modifications in periodic reports. Originally implemented under 21st Century Cures Act provisions.

Source

FDA, 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions' (Aug 2024)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial

How MedTek OS handles this

Compass drafts the predetermined change control plan (pccp) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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