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Updated October 2026 for FDA's final guidance. The 2024 version of this post was based on the 2023 draft.
If you make AI-enabled device software, you will likely retrain or update it after clearance. A predetermined change control plan (PCCP) lets you get those planned changes authorized up front, in your 510k, De Novo or PMA, so that changes made in line with the plan do not each need a new submission.
FDA's guidance for AI-enabled device software functions is final (reissued August 2025), and since October 2026 FDA lists authorized devices with PCCPs on its PCCP web page. This post is a working plan for your team, in five steps. For the full reference on what FDA expects in each part, see our PCCP guide.
Before you start
PCCPs are optional. They suit changes that stay within the intended use, that you can define and test against criteria set in advance, and that you expect to make more than once. Changes that would not need a new submission anyway do not belong in a PCCP. They stay under your design change process, as they do today.
A PCCP also adds review content to your first submission. If the plan is not ready, FDA can authorize the device without it, and you can add a PCCP in a later submission.
1) Pick a short list of changes
Bring Regulatory, Quality, R&D or data science, clinical and product together to build the list. Your product roadmap, past releases and changes you have filed before are good starting points.
The final guidance describes three types of modifications that may be appropriate for AI-enabled device software.
- Performance. Re-training on new data from the intended use population, with the same type and range of input signal, to improve performance.
- Inputs and compatibility. New sources of the same type of input, limited new input types, or compatible hardware, operating system and cloud updates.
- Use and performance. Limited changes such as performance for a specific subpopulation within the population the device is already indicated for.
Keep the list short and specific. For each change, state whether it will be made manually or automatically, whether it applies to all devices or to specific sites, and how often you expect to make it. Leave out changes to the intended use, a new patient population and most changes to the indications for use. Those generally need a new submission.
2) Write the modification protocol
The modification protocol sets out how each change will be developed, tested and released. FDA expects four components for each change.
- Data management. How new data is collected, annotated, curated, stored and controlled, and how test data is kept separate from training and tuning data.
- Re-training. Which parts of the model or processing may change, the methods used, and what triggers a re-training.
- Performance evaluation. The study design, metrics, acceptance criteria and statistical tests, all set before the change is made. Compare each modified version to the original device and to the last modified version.
- Update procedures. How the update is deployed, how users are told, how labeling changes and how you will monitor real-world performance.
State in the protocol that a change with a failure that cannot be resolved is recorded and not released. A traceability table that links each change to its protocol sections makes the plan easier for a reviewer to follow.
3) Assess the impact
The impact assessment compares each change to the version without it, sets out its benefits and risks (including unintended bias), and explains how the protocol controls those risks. It also covers how the changes affect each other and the cumulative effect of all of them together. Tie it to your risk management file so it stays current as changes are made.
4) Build it into your quality system
An authorized PCCP is carried out through your quality system. Each change still goes through design change control, with records that show it followed the protocol. Decide now who approves a change under the PCCP, where the evidence is kept, and how labeling and the version history are updated.
Two points deserve attention. A change that does not follow the authorized protocol generally makes the device adulterated and misbranded, so a deviation usually means a new submission. FDA encourages talking to the review division first about any deviation you think is minor. Also, the guidance still cites sections of the former Quality System regulation, while the QMSR took effect on February 2, 2026, so map those references to your current procedures.
5) Get feedback, then submit
Raise the PCCP in a Pre-Sub before the marketing submission. FDA's Q-Submission guidance highly recommends this and counts a PCCP as one substantial topic, out of the three or four FDA suggests per Pre-Sub. FDA does not authorize a PCCP in a Pre-Sub, so treat the feedback as input to the final plan.
In the submission, the PCCP is its own section with a title and version number. List it in the table of contents as "Predetermined Change Control Plan" and note it in the cover letter. eSTAR has a PCCP checkbox in the device description. Describe the PCCP in the device description, the labeling and the 510k summary or De Novo decision summary. A Special 510k is generally not the route to establish a new PCCP.
Start from the Cosm PCCP template
The Cosm PCCP template is a Word document built around the three parts of a PCCP, with instructions and short example text in each section. Version 2.0 is aligned to FDA's August 2025 PCCP guidance. See the template.
The bigger picture
FDA has also issued a draft guidance that extends PCCPs to all devices, codified the first device type with a PCCP in its special controls, and published a list of authorized devices that includes hardware and diagnostics. For how the guidance changed since the 2023 draft, see FDA's PCCP guidance from the 2023 draft to the final version. More on AI-enabled devices is on our AI/ML SaMD topic page.
How Cosm Can Help
Cosm can help you choose the right changes for a PCCP, write the modification protocol and impact assessment, set up the quality system steps to carry it out, and plan the Pre-Sub. There is no recurring retainer or monthly minimum. Email us or visit cosmhq.com.
Disclaimer - https://www.cosmhq.com/disclaimer
