Free tool · FDA August 2024 guidance
PCCP Generator
Generates a structured draft Predetermined Change Control Plan for an AI/ML medical device. Three sections matching FDA's Aug 2024 guidance: Description of Modifications, Modification Protocol, Impact Assessment. Customize before you submit.
Compass goes deeper
Reasons over your validation evidence, not just the template.
Inside Compass, the PCCP generator pulls your locked test set composition, your historical performance distribution, and your subgroup analyses, then writes the protocol with acceptance criteria backed by your real numbers. Confidence-gated at 0.97, citation-chained to your DHF.
Try the sandboxSource: FDA, "Marketing Submission Recommendations for a Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions" (August 2024). Authority: 21st Century Cures Act provisions.
More free tools