Final FDA guidance on PCCP includes clarification on version control

The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices with artificial intelligence (AI) features. The finalized guidance clarifies the agency’s thoughts on AI versus machine learning (ML) products and adds several sections, including a section on version control of PCCP-enabled devices.

On 3 December, FDA finalized the guidance, which details its expectations for allowing PCCPs for AI-enabled devices. Regulators reiterated that ML is a subset of AI. However, while the draft version focused on providing a forward-thinking approach to ML development, the final version takes a broader approach and says it is intended for AI-enabled device software functions (AI-DSF) more generally.

Many of the changes in the guidance are minor, but two new sections provide more depth to the FDA’s expectations. For instance, the final guidance includes a section on how the agency will address version control and maintenance of PCCPs for marketed devices.

FDA acknowledged that sponsors may gain experience when developing and implementing their PCCPs that will ultimately require changes. The agency said it will need to have interactive discussions to ensure the final version of the sponsor’s PCCP meets its requirements.

“It is possible that a PCCP submitted as part of a marketing submission may need revisions before FDA can make a determination of reasonable assurance of safety and effectiveness or substantial equivalence in review of the device, including each modification in the PCCP, for the PCCP to be authorized with the device,” said FDA. “FDA should work with the manufacturer to revise the PCCP, and will do so using FDA’s existing processes to request additional information through interactive review or through a deficiency letter.”

If deficiencies with the PCCP remain unresolved, FDA may authorize the device upon withdrawal of the PCCP,” the agency added.

FDA noted that a copy of the PCCP with a title and version number needs to be included in the device's marketing submission. If the PCCP is revised during the review process, a clean copy needs to be submitted to the agency.

According to the FDA, if the manufacturer wants to update the PCCP for their product after it has gone to market, it may need to make a new submission. Furthermore, the agency noted that any modifications that have been made to the product based on the authorized PCCP also need to be summarized in the submission. However, it assured manufacturers it does not intend to re-review the adequacy of the initially authorized PCCPs but needs the information to ensure the current version of the device meets its regulatory requirements.

“Additionally, if the manufacturer would also like to modify their previously authorized PCCP, the marketing submission must include the appropriate marketing submission requirements and the proposed, modified PCCP for the device (see Section V.E. of this guidance),” said FDA. “For devices subject to 510(k) requirements, a manufacturer must compare their subject device to the version of the predicate device cleared or approved prior to changes made under the PCCP.”

“However, once a 510(k) for a device that includes modifications that have been implemented consistent with the authorized PCCP has been cleared in a subsequent marketing submission, such device can now serve as an eligible predicate device,” the agency added.

Another major addition to the draft guidance is the appendices, where the FDA provides examples of AI-DSF scenarios where sponsors may use PCCPs. The agency added an example of an optical imaging system packaged with an imaging drug. The example addresses post-authorization scenarios, such as when the manufacturer modifies the device based on the authorized PCCP and when the device has been used after modification that was not specified in the original PCCP.

FDA clarifies that only products it oversees for marketing authorization are appropriate for PCCP.

“Premarket authorization for an AI-DSF with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway, as appropriate, as a PCCP must be reviewed and established as part of a marketing authorization, for a device prior to a manufacturer implementing any modifications under that PCCP,” said the agency. “Correspondingly, submission types for which FDA does not make an affirmative decision (i.e., authorization) would not be appropriate to establish a PCCP.”

Final guidance

Final FDA guidance on PCCP includes clarification on version control

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