FDA Final Guidance Sets Out Change Control Plans for AI-Enabled Device Software

The guidance explains how manufacturers can describe, in a premarket submission, the changes they plan to make to an AI-enabled device software function after the device reaches the market. Once FDA authorises a predetermined change control plan, modifications that fall within the plan and are implemented in line with it do not require a new marketing submission. According to law-firm summaries of the final text, such changes are documented within the manufacturer’s quality management system instead.

The legal basis is section 515C of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Omnibus Reform Act as part of Public Law 117-328, enacted on 29 December 2022 and codified at 21 U.S.C. 360e-4. The statute allows FDA to approve PCCPs submitted in premarket approval applications and supplements and to clear PCCPs submitted in 510(k) notifications. FDA has also stated that a PCCP can be established through the De Novo pathway.

FDA describes the PCCP as fully optional. Manufacturers that do not use one can continue to seek authorisation for each significant change through separate submissions under the existing device modification policies.

The 2023 draft applied only to machine learning-enabled device software functions. The final guidance widens the scope to all AI-enabled device software functions, although commentators note that it remains most relevant to machine learning models that are retrained or updated over time. The FDA document states that it applies to models modified automatically, manually, or through a combination of both.

The final text also added a section on version control and maintenance of the PCCP, under which manufacturers should clearly indicate the title and current version of the plan when it is revised, for example in response to deficiencies raised during review. Several law firms reported that the final guidance otherwise stays close to the draft structure.

FDA’s guidance listing presents the document as an August 2025 final guidance, while law firms and trade press dated its original finalisation to December 2024. The nature of any changes made in the August 2025 version could not be confirmed from the sources available at the time of checking, so readers should consult the version history on the FDA page.

FDA recommends three components. The Description of Modifications lists the specific planned changes and their rationale. The Modification Protocol sets out how each change will be developed, validated and implemented; summaries of the guidance identify data management practices, retraining practices and performance evaluation protocols among its elements, and Appendix A gives example protocol content. The Impact Assessment documents the benefits and risks of the planned changes and how risks will be mitigated. Appendix B provides worked example scenarios.

Summaries of the guidance state that the labelling of a device with an authorised PCCP should tell users that the device incorporates machine learning and has an authorised plan, so that they understand the device may change after they begin to use it. A change that falls outside the authorised plan, or that is not carried out according to the protocol, is assessed under the ordinary modification rules, and law firms note that deviating from an authorised PCCP may render a device adulterated or misbranded.

A PCCP can accompany a traditional or abbreviated 510(k), a De Novo request or a PMA. It cannot be included in a Special 510(k), although commentators report that a Special 510(k) may be used later to modify a PCCP that has already been authorised. For 510(k) devices, the PCCP is reviewed as part of the substantial equivalence determination; where a predicate device had a PCCP, the comparison is made to the predicate as originally cleared.

A separate draft guidance, Predetermined Change Control Plans for Medical Devices, issued on 22 August 2024, would extend the approach to all device types. It had not been finalised at the time of checking; trade reporting in October 2026 indicates that CDRH placed its finalisation on the priority list of its fiscal year 2027 guidance agenda. Manufacturers should therefore treat the AI-specific document as the current final reference and plan PCCP discussions with FDA through the pre-submission programme before filing.