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Make an AI/ML SaMD predetermined change control plan (PCCP) audit-ready by defining exactly which changes are allowed, setting an executable evidence and testing protocol before making them, and documenting how each change affects the device’s risks and performance. Preserve a versioned record from the authorized plan through release and postmarket monitoring. No plan can guarantee an audit outcome, and a PCCP is not blanket permission to change a device.
What a PCCP authorizes—and what it does not
For U.S. FDA submissions, a PCCP is reviewed as part of a device’s marketing submission. FDA’s final guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, dated August 2025, addresses AI-enabled device software functions (AI-DSFs), including device constituent parts of device-led combination products, submitted through 510(k), De Novo, and PMA pathways. A change implemented in accordance with an authorized PCCP may not require its own new marketing submission, but only if it remains within the plan’s authorized boundaries and applicable requirements.
The guidance is generally nonbinding: FDA uses “should” to indicate a recommendation unless a statutory or regulatory requirement applies. A PCCP must be established through marketing authorization; it is not an internal change log that a manufacturer can apply retroactively. The joint FDA, Health Canada, and MHRA guiding principles offer a useful design lens, but jurisdictions may implement PCCPs differently. FDA authorization does not establish permission in other markets.
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What evidence belongs in the three linked PCCP sections?
FDA’s recommended structure has three sections. They should describe the same bounded changes and form one traceable argument: what will change, how the change will be controlled and tested, and why the resulting device remains acceptably safe and effective.
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| Section | Question it answers | What to define |
|---|---|---|
| Description of Modifications | What changes are in scope? | Specific proposed modifications, expected characteristics and performance, relevant intended use, populations and environments, and explicit boundaries. |
| Modification Protocol | How will each change be developed, evaluated and released? | Data management, retraining methods and triggers, performance evaluation, predefined acceptance criteria, update procedures, and actions if testing fails. |
| Impact Assessment | Why are the planned changes and controls acceptable for the device as a whole? | Benefits, hazards, risks, mitigations, residual risk, and effects of individual and cumulative modifications on the AI-DSF and overall device. |
Bound the Description of Modifications
Describe changes precisely enough that a reviewer can determine whether a future update fits the plan. Define the characteristics and expected performance of the modified function and the relevant intended use, indications, populations, or use environments. State what is outside scope, not just what is included. A vague promise to improve performance through future model updates does not establish a meaningful boundary.
FDA says changes in a PCCP must maintain intended use and, where applicable, substantial equivalence; it generally expects the device to remain within its indications for use. Because prospectively assessing many indication changes can be difficult, FDA encourages manufacturers to discuss uncertain boundaries with the relevant review division through the Q-Submission program.
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Make the Modification Protocol executable
Write the protocol as a procedure that another qualified person could follow, rather than a commitment to “revalidate” an update later. For each planned change, specify the data, methods, tests, decisions, and release controls. At minimum, address:
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- Retraining: Define triggers and methods, along with controls for overfitting and bias.
- Performance evaluation: State when evaluation is triggered; identify independent, sequestered test data; and set clinically justified metrics, statistical analyses, sample-size rationale, relevant high-risk populations, and challenging cases.
- Acceptance decisions: Set criteria in advance and explain how device-level safety and effectiveness will be assessed. Consider whether improving one metric could cause an unacceptable degradation in another population, task, or outcome.
- Implementation: Define whether updates are automatic or manual, how software versions are controlled, who authorizes release, and what stop or rollback mechanisms are available.
- Communication and surveillance: Specify relevant user communications, instructions or training updates, and post-implementation monitoring of safety and effectiveness.
Choose evidence and criteria that fit the device, its intended use, and the risks of the particular modification. FDA does not endorse one universal template or a single quantitative threshold for every device.
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Decide in advance what happens when testing fails
If a planned change does not meet its predefined criteria and the failure cannot be resolved, record the failure and do not implement that modification. A root-cause analysis may support repeating a test when the cause is unrelated to aspects of the PCCP; document the reason and rationale for retesting. Do not silently rerun evaluations until a passing result appears.
Use the Impact Assessment to connect risks to controls
For each modification, identify expected benefits, hazards, risks, mitigations, and residual risks. Consider the AI-DSF and the device as a whole, including interactions with other software functions or hardware where relevant. Assess both individual changes and their cumulative effects. Explain why the protocol’s data and controls are sufficient to preserve safe and effective performance across the intended populations and environments.
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How do you make the plan and its implementation traceable?
FDA recommends presenting the PCCP as a standalone section in the marketing submission, with a title and version number. Refer to it prominently in the cover letter and table of contents, and cross-reference it from other submission sections that discuss its content. If the plan changes during review, submit a clean final version with a current version number. The authorized plan is referenced in the device’s authorization letter.
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For each implementation, retain records that let an independent reviewer reconstruct what happened and why. Organize them around the change request and the applicable authorized plan version, including:
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- The request, rationale, and documented decision that the proposed change is within scope.
- Data provenance, inclusion and exclusion decisions, and training, tuning, and test partitions.
- The protocol version and execution records, metric results, subgroup and challenging-case results, and acceptance decision.
- The impact assessment, risk controls, deviations, failed tests, root-cause analyses, and any retest rationale.
- Release authorization, software and version records, rollback readiness, updated labeling or instructions, training, and user notices.
- Postmarket safety and performance monitoring after implementation.
This record set is a practical way to implement FDA’s recommendations, not a separately published FDA audit checklist. The test results alone are not the full evidence trail: the scope decision, methods, risk reasoning, release decision, and follow-up all need to connect to the same modification.
What should users be told about a PCCP-driven update?
FDA recommends labeling that informs users that the device uses machine learning and has an authorized PCCP, and that updates may affect performance, inputs, or use. As applicable, labeling updates can explain the modifications made, current performance, relevant training, tuning, and test data, inputs and outputs, validation requirements and evidence, how the changes were implemented, and how users are notified—for example, through revised instructions or version history.
When does an AI/ML device change need a new FDA submission?
A manufacturer should not describe a change as covered by the PCCP if it falls outside the authorized scope or if the plan cannot be followed. FDA describes failure to follow, or inability to follow, the authorized plan as a deviation; significant out-of-plan modifications likely require a new marketing submission before implementation. A manufacturer may also choose not to use an authorized PCCP or may submit a new marketing submission instead. The appropriate regulatory path depends on the device and the specific change.
In practice, test a proposed update against the authorized Description of Modifications first. If it fits, carry it through the Modification Protocol and document its risks through the Impact Assessment. If the scope is uncertain, or the change may alter intended use or indications, seek appropriate regulatory advice and consider early FDA engagement rather than treating the existing PCCP as automatic coverage.
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