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Updated October 2026. This post first covered FDA's April 2023 draft guidance. It now reflects the final guidance and what has happened since.
In April 2023, FDA published a draft guidance on predetermined change control plans (PCCPs) for machine learning-enabled device software functions. A PCCP lets a manufacturer describe planned changes to a device, and how each one will be developed, tested and rolled out, in the marketing submission. Once FDA authorizes the plan, changes made in line with it do not need a new 510k or PMA supplement.
A lot has moved since that draft. The guidance is final, FDA has issued a second draft that covers all devices, a PCCP now appears in the special controls of a device classification regulation, and FDA launched a PCCP web page in October 2026 with a list of authorized devices. Below is what changed and what it means if your plans were built on the 2023 draft.
The legal basis
PCCPs rest on section 515C of the FD&C Act, added by the Food and Drug Omnibus Reform Act (FDORA) in December 2022. It lets FDA clear or approve a plan for changes that would otherwise need a new 510k or a PMA supplement. FDA establishes PCCPs in De Novo requests under section 513(f)(2). In March 2024, FDA amended its 510k and PMA regulations so that a change consistent with an authorized PCCP does not need a new submission.
From draft to final
FDA finalized the guidance in December 2024 and reissued it on August 18, 2025. The current title is Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
The core structure did not change. A PCCP still has three parts.
- Description of modifications. The specific planned changes and the rationale for each, including whether they will be made manually or automatically, and across all devices or site by site.
- Modification protocol. For each change, the data management practices, re-training practices, performance evaluation and update procedures.
- Impact assessment. The benefits and risks of each change, how the changes affect each other, and their combined effect.
In its notice announcing the final guidance, FDA described these changes from the draft.
- The title moved from "AI/ML-enabled" to "artificial intelligence-enabled."
- Clarifications on scope, on PCCP information in labeling and public decision summaries, on implementing modifications consistent with an authorized PCCP, and on postmarket surveillance.
- Revised definitions of AI and ML, and clearer terms for training, tuning and test data.
There was no Federal Register notice or summary of changes with the August 2025 reissue. The visible difference is in the definitions. The December 2024 version aligned its AI and ML definitions with Executive Order 14110, which was revoked in January 2025. The August 2025 version cites the statutory definitions in 15 U.S.C. 9401 instead. When you cite the guidance, cite the August 2025 version.
Points in the final guidance worth rereading
If you last read the 2023 draft, these points from the final guidance deserve a second look.
- Keep the list short. FDA recommends "only a limited number of modifications that are specific, and that can be verified and validated."
- Test against two baselines. Each modified version is compared to both the original device and the last modified version.
- Say what happens when a change fails. The protocol should state that a modification with a failure that cannot be resolved is recorded and not implemented.
- Label what is implemented, not what is planned. Labeling should state that the device has an authorized PCCP. It should not describe changes that have not been made yet.
- Use the Pre-Sub, and know its limits. FDA encourages feedback on a proposed PCCP through the Q-Submission Program, but a Pre-Sub does not authorize a PCCP.
- Mind the predicate. Only the version cleared before any PCCP changes can serve as a predicate, until a later 510k clears a modified version.
Our PCCP guide covers each of these in more detail, with a decision path and a submission checklist.
What has happened since
A draft guidance for all devices
In August 2024, FDA issued a draft guidance, Predetermined Change Control Plans for Medical Devices, that applies the same approach to hardware, diagnostics and other devices. It adds guiding principles, flowcharts and examples of changes that are generally appropriate or not appropriate for a PCCP on each pathway. It is still a draft and is on CDRH's list of final guidances planned for fiscal year 2027. FDA has said section 515C is self-executing, so a PCCP can be submitted for any device now.
The first classification regulation with a PCCP
In June 2026, FDA codified 21 CFR 892.2055 for radiological machine learning-based quantitative imaging software with a PCCP. It comes from a De Novo granted in February 2023. Its special controls require manufacturers to document the planned modifications and the methods used to develop, verify and validate them, to assess their risks, and to label the device with a PCCP statement and a version history.
An FDA web page and a list of authorized devices
On October 20, 2026, FDA published a PCCP web page. It explains what a PCCP is, which submissions can include one and where it goes in the submission. It also lists authorized devices with PCCPs, with decisions starting in 2023. The list includes cardiac implants, slide scanners and laboratory tests as well as AI software, so PCCPs are already in use well beyond AI.
Outside the US
FDA, Health Canada and MHRA published five shared guiding principles for PCCPs in October 2023. IMDRF finalized N90, Essential Principles and Content of Predetermined Change Control Plans, for medical device software in 2026. Health Canada's pre-market guidance for machine learning-enabled medical devices has been final since February 2025. Under the EU AI Act, changes to a high-risk AI system that continues to learn are not a substantial modification if they were pre-determined at the initial conformity assessment and documented in the technical documentation. MHRA has said it intends to publish draft PCCP guidance by December 2026.
What this means if your plan was built on the 2023 draft
Update the references. Cite the August 2025 final guidance and use its terms. It uses AI-DSF where the draft used ML-DSF, along with clearer terms for training, tuning and test data. A plan that still cites the 2023 draft may read as out of date to a reviewer.
Recheck scope if your device is not software only. The August 2024 draft lists changes FDA generally considers appropriate or not for a PCCP on each pathway. It is not final, but it shows how FDA is thinking about hardware and diagnostics.
Plan the labeling early. FDA expects labeling to say the device has an authorized PCCP and to describe changes as they are made, with a version history. Building that into your labeling process now saves rework later.
Map the guidance to the QMSR. The guidance still cites sections of the former Quality System regulation. The QMSR took effect on February 2, 2026, so map those references to your current procedures for design changes and records.
Raise the PCCP early with FDA. FDA's Q-Submission guidance highly recommends Pre-Subs for PCCPs and counts a PCCP as a substantial topic, so plan the Pre-Sub around it.
The bigger picture
In three years, FDA's approach has moved from a draft for machine learning software to a final guidance for AI-enabled software, a draft for all devices, a codified device type and a public list of authorized devices. The all-device guidance is on FDA's list for fiscal year 2027, and the UK and EU are working on their own mechanisms. For the practical steps, see how to create an FDA PCCP in five steps. For how PCCPs fit the wider AI lifecycle, see our post on the AI lifecycle management model and our AI/ML SaMD topic page.
The final AI guidance, the all-device draft, the guiding principles and IMDRF N90 are all in the Cosm library.
How Cosm Can Help
Cosm helps teams decide whether a PCCP fits their roadmap, write the description of modifications, modification protocol and impact assessment, and raise the plan with FDA in a Pre-Sub before the 510k, De Novo or PMA. If you would rather start on your own, the Cosm PCCP template follows the same three parts. There is no recurring retainer or monthly minimum. Email us or visit cosmhq.com.
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