The short answer
A Predetermined Change Control Plan (PCCP) lets you get FDA authorization now for specific model updates you plan to make later. If a later change is listed in the authorized plan and you carry it out exactly as the plan says, you do not need a new 510(k), De Novo or PMA supplement for it. You document it in your quality system instead. Congress created PCCPs in section 515C of the FD&C Act (FDORA, Dec 2022). FDA's final guidance for AI-enabled device software functions explains what to put in one.
Sources: FD&C Act sec. 515C (21 U.S.C. 360e-4); FDA PCCP final guidance for AI-enabled device software functions (Dec 2024, updated Aug 2025). This page is a summary, not regulatory advice for a specific device.
What a PCCP is
FDA defines a PCCP as “The documentation describing what modifications will be made to a device and how the modifications will be assessed.” FDA reviews it as part of your marketing submission, “without necessitating additional marketing submissions for implementing each modification described in the PCCP.”
It can cover changes a person makes by hand, changes the software makes automatically, or both. Under the statute, FDA may require a PCCP to include labeling, “notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.”
Put it in its own section of the submission, titled “Predetermined Change Control Plan”, with a version number. FDA recommends the labeling say the device has an authorized PCCP. The public 510(k) summary, De Novo decision summary or PMA SSED should describe it too.
Sources: FDA PCCP final guidance; FD&C Act sec. 515C (21 U.S.C. 360e-4).
The three components
| Component | What it contains |
|---|---|
| Description of Modifications | The specific planned changes. FDA recommends “only a limited number of modifications that are specific, and that can be verified and validated.” Say whether each is automatic or manual, global or local, and how often you expect to update. |
| Modification Protocol | How each change is developed, validated and rolled out: data management, re-training, performance evaluation and update procedures, with “pre-defined acceptance criteria.” |
| Impact Assessment | “The assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.” Covers each change alone, interactions between changes, and their cumulative effect. |
The Modification Protocol has four parts. Data management: how new data is collected, labeled and stored, and how test data stays sequestered from training and tuning data. Re-training: what gets re-trained and what triggers it, for example a set amount of new data. Performance evaluation: test each modified version against the original and the last modified version. If a change fails, record it and do not ship it. Update procedures: how you deploy, update labeling and tell users, and how you monitor real-world performance. FDA suggests a traceability table that maps each planned change to the protocol steps that cover it.
Source: FDA PCCP final guidance, sections VI to VIII.
Which changes fit a PCCP and which need a new submission
Changes in a PCCP “must maintain the device within the device's intended use.” FDA also expects them to stay within the indications for use. A change counts as covered only if it “has been specified in the Description of Modifications” and “has been implemented in accordance with the Modification Protocol.”
| Planned change | Usual answer |
|---|---|
| Re-training on new data from the intended use population, same type and range of input signal | Likely fits (FDA example type: performance specifications) |
| New sources of the same input signal type, e.g. another scanner or sensor model meeting stated specs; compatible hardware, OS or cloud updates | Likely fits (FDA example type: device inputs and compatibility) |
| Better performance in a specific subpopulation inside the already-indicated population | May fit (FDA example type: certain use and performance changes) |
| A new clinical claim, e.g. predicting an event in advance when the device only detected it | New submission (FDA hypothetical example) |
| A new input type such as a different imaging modality, or a new user group such as patients instead of clinicians | New submission (FDA hypothetical examples) |
| Any change outside the intended use, or not listed in the PCCP, or not done per the protocol | New submission likely; assess under FDA's device-change guidances |
Changing the authorized plan itself generally needs a new marketing submission. In some cases a Special 510(k) may be the right route.
Source: FDA PCCP final guidance, sections V.D, V.E, VI.C and Appendix B. The new-submission rows are FDA's hypothetical examples, not rulings on real devices.
How it relates to 510(k), De Novo and PMA
A PCCP is not a separate pathway. You add it to a marketing submission you are already making.
| Pathway | Where a PCCP can be authorized | What changes |
|---|---|---|
| 510(k) | Traditional or Abbreviated 510(k) | Device must remain substantially equivalent to the predicate. Later 510(k)s compare to the predicate version cleared before PCCP changes. |
| De Novo | Original De Novo request | FDA may write special controls, which “may include specific requirements for a PCCP.” |
| PMA | Original or modular PMA; 180-day, panel-track or real-time supplement | No PMA supplement is needed for a change consistent with an approved PCCP. |
FDA does not authorize a PCCP in a Pre-Submission, but it encourages using the Q-Submission Program to get feedback on a proposed plan first. Only the version cleared or approved before any PCCP changes “may be used by a sponsor as a predicate device.”
Sources: FD&C Act sec. 515C (21 U.S.C. 360e-4); FDA PCCP final guidance, sections III and V.B.
Two cleared examples
FDA's FDA AI-Enabled Medical Devices list links each device to its database record. Some entries carry the suffix “(with PCCP)”. Their public 510(k) summaries show what FDA accepted.
Fibresolve (with PCCP), K252041, Imvaria, Inc., cleared Nov 7, 2025. This is lung-CT software that classifies suspected interstitial lung disease. The 510(k) added a PCCP to the original De Novo device. The planned changes are “model architecture modification, introduction of new training data, and incorporation of ancillary inputs (while maintaining original inputs).” Each change is evaluated with pre-specified statistics “to ensure, at minimum, non-inferior absolute performance.”
Tyto Insights for Wheeze Detection (with PCCP), K252844, Tyto Care, Ltd., cleared Jun 2, 2026. This is over-the-counter software that flags suspected wheeze in lung sounds recorded by the Tyto Stethoscope. It lists three changes: re-training with more data on the same type and range of input signal; preprocessing, augmentation and hyperparameter changes “without modifications to the core model architecture, intended use, or output of the device”; and other FDA-cleared electronic stethoscopes with equivalent audio specs. Each change passes only if the lower 95% confidence bounds for sensitivity and specificity are no lower than those of the most recently released version. Results are also reported by age group, gender, user type and stethoscope model.
Sources: K252041 clearance letter and 510(k) summary; K252844 clearance letter and 510(k) summary; FDA AI-Enabled Medical Devices list.
Practical checklist
- Pick a short list of specific changes you expect in the next few years. Leave out anything that changes the intended use or adds a new claim.
- For each change, say whether it is manual or automatic, global or local, and how often you expect it.
- Fix the acceptance criteria now, including confidence-bound rules and subgroups, and compare against both the original and the latest version.
- Keep a sequestered test set and write down what triggers re-training.
- Write the Impact Assessment per change and for all changes combined, including unintended bias.
- Plan the update steps: version numbers, labeling, user notice and real-world monitoring.
- Add a traceability table from each change to its protocol steps.
- Ask FDA for feedback through a Q-Submission before you file.
- After clearance, record each change in your quality system, and check that it matches the plan before release.
Sources: FDA PCCP final guidance; FDA AI-enabled device software functions draft guidance, Jan 2025. The checklist is our practice summary. FDA's January 2025 AI guidance is a draft and is not for implementation. It suggests a PCCP as one way to handle performance drift found by postmarket monitoring.
Related resources
Frequently asked questions
What is a PCCP for an AI medical device?
A Predetermined Change Control Plan is the part of an FDA marketing submission that describes what modifications will be made to a device and how they will be assessed. Once FDA authorizes it, changes made in line with the plan do not need a new 510(k), De Novo or PMA supplement.
What are the three parts of a PCCP?
A Description of Modifications, a Modification Protocol and an Impact Assessment. The protocol covers data management, re-training, performance evaluation and update procedures, with acceptance criteria set in advance.
Can a PCCP cover a new indication or intended use?
No for intended use: changes must keep the device within its intended use. FDA also expects them to stay within the indications for use. A new clinical claim, input type or user group generally needs a new submission.
Can FDA authorize a PCCP in a Pre-Submission?
No. FDA does not authorize a PCCP in a Pre-Submission. It reviews the plan as part of a 510(k), De Novo or PMA submission, but it encourages a Q-Submission for feedback on a proposed plan first.
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