What it is
A predetermined change control plan (PCCP) lets a manufacturer describe planned modifications to an AI-enabled device in its marketing submission, so that those changes can be made later without a new submission, as long as they follow the authorized plan.
FDA first issued this guidance as final in December 2024 (the FDA Roundup posted it on 3 December 2024; a webinar followed on 14 January 2025). FDA’s guidance list now shows an issue date of 18 August 2025 (Final). We could not confirm what changed in the August 2025 version. Docket: FDA-2022-D-2628.
The three components
| Component | What it covers |
|---|---|
| Description of modifications | The specific planned changes |
| Modification protocol | Methods to develop, validate, and implement them |
| Impact assessment | Benefits, risks, and mitigations |
It applies to 510(k), De Novo, and PMA submissions, and to the device part of device-led combination products. Compared with the April 2023 draft, the final scope widened from “ML-enabled” to AI-enabled device software functions, allows a Special 510(k) to modify an authorized PCCP, and adds guidance on version control and labeling.
Related guidance
FDA’s January 2025 draft on lifecycle management of AI-enabled device software functions is the companion document (see the next article). A final Clinical Decision Support Software guidance was issued on 29 January 2026.
Reuse terms
FDA content is public domain unless otherwise noted; credit is appreciated, and FDA suggests recording the date copied. Third-party material and FDA logos are outside this.
Using the guidance in AI and RAG
- Index the current version with the August 2025 list date, and note the original December 2024 issue.
- Link each PCCP to its device and version history.
- Tag the three components for gap checks.
- Track which model changes fall inside the authorized plan.
- Keep the lifecycle draft as a separate, draft-labeled document.
Common mistakes
- Making changes outside the authorized PCCP without a new submission.
- Treating a PCCP as a general permission to retrain.
- Citing the 2023 draft wording.
- Missing labeling and version control expectations.
Checklist
- Current guidance version indexed
- Three components documented per device
- Change log mapped to the PCCP
- Labeling and version control addressed
- Lifecycle draft linked as draft
How AskDona helps
AskDona compares your PCCP and change records with the guidance’s components and shows which planned changes are covered and where evidence is missing.
Run a sample PCCP completeness check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “conditions to check” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
What is a PCCP? A plan, authorized in the marketing submission, for specific future modifications to an AI-enabled device.
Is the PCCP guidance final? Yes. It was issued as final in December 2024; FDA’s list now shows 18 August 2025.
Which pathways does it cover? 510(k), De Novo, and PMA.
What are the three components? Description of modifications, modification protocol, and impact assessment.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| FDA: PCCP guidance page | Final status, date, components, pathways |
| FDA Roundup, 3 Dec 2024 | Original final release |
| FDA: Webinar transcript (PDF) | Changes from draft, three components |
| FDA: Digital health guidances | Status table, CDS final guidance |
| FDA: Website policies | Public domain reuse |