Short answer (updated Oct 17, 2026): a predetermined change control plan (PCCP) lets an AI-enabled device maker get planned model updates reviewed up front, so each change described in the plan doesn't need a new marketing submission. FDA's final guidance on PCCPs for AI-enabled device software functions was first issued Dec 4, 2024 and reissued Aug 18, 2025 (docket FDA-2022-D-2628).
Key facts
| Guidance | Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (final) |
|---|---|
| First issued | Dec 4, 2024 (Federal Register 2024-28361) |
| Current version | Aug 18, 2025 |
| Docket | FDA-2022-D-2628 |
| Pathways | 510(k), De Novo and PMA |
What a PCCP contains
- Description of modifications: the specific changes planned for the AI-enabled device.
- Modification protocol: how each change will be developed, validated and implemented.
- Impact assessment: an assessment of the impact of those modifications.
What's next
CDRH's FY2027 guidance agenda lists finalizing a separate, broader PCCP guidance for medical devices in general (drafted in August 2024) as a top priority, alongside finalizing the January 2025 draft on lifecycle management of AI-enabled device software functions, according to RAPS.
Related
Sources
- FDA guidance page (PCCP for AI-enabled device software functions)
- Federal Register notice of availability, Dec 4, 2024
- RAPS Regulatory Focus: CDRH FY2027 guidance agenda
FAQ
What is a PCCP?
A predetermined change control plan describes planned modifications to an AI-enabled device, how they will be developed, validated and implemented, and an assessment of their impact. FDA reviews it with the marketing submission.
Is FDA's AI PCCP guidance final?
Yes. It was first issued as final guidance on Dec 4, 2024 and reissued on Aug 18, 2025.
Which submissions can include a PCCP?
510(k), De Novo and PMA submissions for AI-enabled devices, according to the guidance.