An approved or cleared Predetermined Change Control Plan (PCCP) lets a manufacturer make changes consistent with the plan without an otherwise required new 510(k) or PMA supplement under FDA’s framework. When reviewing an AI medical device update, the question is whether the change fits that plan.
Key Takeaways
- A PCCP must be reviewed and established within a device’s marketing authorization before a manufacturer implements modifications under it.
- FDA recommends a Description of Modifications, a Modification Protocol, and an Impact Assessment covering the planned changes.
- The guidance is nonbinding, but FDA says deviations from an authorized PCCP would generally cause adulteration and misbranding.
What a PCCP covers for AI medical devices
A Predetermined Change Control Plan, or PCCP, describes specific future device modifications, the methods for making them, and their benefits and risks. FDA’s guidance addresses these plans for artificial intelligence-enabled device software functions. The plan connects what a manufacturer proposes to change with how it will develop, validate, and implement those modifications.
Think of a PCCP as an authorized plan for specified changes. Its scope comes from the planned modifications and their associated specifications, validation activities, and impact assessment. The guidance focuses on continued safety and effectiveness across the device’s intended use populations.
For your team, start the discussion with the proposed modification itself. Match the update to its description, the corresponding validation method, and the assessed benefits and risks. Treat these as questions for the manufacturer, without assuming that every future update falls within the plan.
For related reading, pair this review with evaluating AI vendor accuracy claims in hospital procurement. Keep your PCCP questions specific: what change is described, what evidence will support it, and what acceptance criteria apply?
The law behind PCCPs and the status of FDA’s guidance
Section 515C of the Federal Food, Drug, and Cosmetic Act provides the statutory basis for PCCPs. As FDA explains, a change consistent with an approved or cleared PCCP does not require a PMA supplement or new 510(k) that would otherwise be required.
Section 3308 of the Food and Drug Omnibus Reform Act of 2022, or FDORA, added section 515C. FDORA was enacted on December 29, 2022. The provisions address PCCPs for devices requiring premarket approval or premarket notification.
The concept appeared earlier in FDA’s April 2019 discussion paper on modifications to AI/ML-based software as a medical device. That paper described a PCCP that could accompany a marketing submission to support iterative development. FDA’s final guidance was originally issued on December 4, 2024; the current document was issued on August 18, 2025.
Keep the statute and the guidance distinct when briefing your colleagues. The guidance presents FDA’s recommendations and current thinking; it does not establish rights or bind FDA or the public. Refer questions about the legal effect of a particular plan or modification to counsel or the regulator.
How the three components connect scope, testing, and risk
FDA recommends three connected PCCP components: a Description of Modifications, a Modification Protocol, and an Impact Assessment. Together, they describe the planned changes, the methods for developing and implementing them, and the benefits and risks. The protocol includes verification and validation activities with predefined acceptance criteria.
| Component | Content described by FDA |
|---|---|
| Description of Modifications | Specific planned modifications, including specifications for their characteristics and performance. |
| Modification Protocol | Methods to develop, validate, and implement modifications, including verification, validation, and predefined acceptance criteria. |
| Impact Assessment | Benefits and risks of planned modifications, risk mitigations, and their connection to verification and validation. |
Description of Modifications means the specified scope of planned change. FDA recommends defining both the characteristics and performance of the modifications. For your review, identify the specifications describing the proposed update and use them to frame the discussion about testing.
Modification Protocol means the methodology for developing, validating, and implementing those changes. FDA recommends verification and validation activities that support each modification, including predefined acceptance criteria. Those activities should address continued safety and effectiveness across the intended use populations.
A useful technical question is how the protocol connects each modification to its supporting activities and acceptance criteria. Keep the intended use populations in view when discussing that connection. Take the same questions into your reading of One Model, Many Hospitals: The Sprawl Problem.
Impact Assessment means the evaluation of planned benefits, risks, and mitigations. FDA describes it as the connection between the modification description and the protocol. It addresses how the verification and validation activities will continue to assure device safety and effectiveness.
Read these components together when evaluating a manufacturer’s explanation. Trace an identified risk back to the planned modification and forward to the activities intended to address it. Use any missing connection as a question for the regulatory discussion, rather than filling it with an assumption.
The plan must be authorized before changes are implemented
A PCCP must be reviewed and established as part of a device’s marketing authorization before modifications are implemented under it. FDA identifies PMA, 510(k), and De Novo as pathways through which an AI-enabled device software function with a PCCP may receive premarket authorization, as appropriate.
The sequence matters when your team discusses an update: authorization of the plan precedes implementation under that plan. FDA’s stated condition concerns an approved or cleared PCCP and a change consistent with it. A proposed plan alone does not meet that description.
Request an explanation of where the PCCP sits within the device’s marketing authorization and how the proposed update fits it. Compare that explanation with the authorized modification description and protocol. Bring uncertainty about the appropriate pathway or the scope of authorization to regulatory counsel or FDA.
When a change falls outside the authorized plan
FDA says deviations from the authorized PCCP reviewed in the marketing submission would generally cause a device to be adulterated and misbranded. The guidance cites sections 501(f)(1) and 502(o) of the FD&C Act, respectively. Its wording makes consistency with the authorized plan central to the regulatory discussion.
Keep the word “generally” in any summary of that statement. For a particular update, ask counsel or FDA to assess the proposed change against the authorized plan. Frame the discussion around its specific modifications, validation activities, acceptance criteria, and assessed risks.
Frequently Asked Questions
What is a Predetermined Change Control Plan?
A PCCP is a plan for specified device modifications, their development and validation methods, and their benefits and risks. It must be reviewed and established within a device’s marketing authorization before modifications are implemented under it.
What law provides the basis for PCCPs?
Section 3308 of FDORA, enacted on December 29, 2022, added section 515C to the Federal Food, Drug, and Cosmetic Act. It provides for changes consistent with an FDA-approved or cleared PCCP without an otherwise required PMA supplement or new 510(k).
What components does FDA recommend for a PCCP?
FDA recommends a Description of Modifications, a Modification Protocol, and an Impact Assessment. They cover the specified changes, methods and acceptance criteria supporting those changes, and the benefits, risks, and mitigations associated with them.
When must a PCCP be authorized?
FDA says a PCCP must be reviewed and established as part of a device’s marketing authorization before a manufacturer implements modifications under it. The guidance identifies PMA, 510(k), and De Novo as available pathways, as appropriate.
Sources
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. U.S. Food and Drug Administration. Final guidance for industry and FDA staff, issued August 18, 2025; originally issued December 4, 2024.
This article is for general information and is not legal, regulatory or medical advice.