On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
The guidance finalizes core concepts of predetermined change control plans (PCCPs), which manufacturers of artificial intelligence (AI)-enabled medical devices can leverage to avoid having to create new marketing submissions each time they wish to significantly modify their devices following 510(k) clearance, de novo authorization, or premarket approval.
Manufacturers are generally required to submit new marketing applications to the FDA for review when a software modification could significantly alter that device’s safety and effectiveness. PCCPs are supplemental documentation that manufacturers of medical devices may include as part of typical marketing submissions, and they provide manufacturers with an avenue to avoid that burdensome process entirely. Comprising at least three sections – a description of modifications, a modification protocol, and an impact assessment – PCCPs are intended to notify the FDA of anticipated modifications to a device that may alter its safety and effectiveness. If the FDA authorizes a manufacturer’s PCCP, that manufacturer can implement modifications in line with the PCCP without having to submit new marketing applications.
The FDA specifies that a device manufacturer stays within the bounds of an authorized PCCP when it:
The final guidance finalizes previous draft guidance, which we covered in April 2023, and clarifies the FDA’s view of PCCPs in the AI-enabled medical device context. The guidance also discusses how manufacturers should leverage the PCCP process and the content that should be included in their PCCPs. Because many of the FDA’s substantive recommendations remain unchanged from the draft guidance, this +Insight highlights changes that the FDA made in the final guidance, rather than providing a comprehensive outline of the guidance’s contents. Affected manufacturers should review the final guidance to see the FDA’s full suite of suggestions.
DEFINITIONS
The FDA broadened the scope of its guidance to cover all AI-enabled medical devices, rather than just machine-learning-enabled devices, a subset that the draft guidance focused on exclusively.
In keeping with this change, the FDA defines terms such as “artificial intelligence” and “machine learning”:
GENERAL CHANGES TO THE GUIDANCE
Throughout the guidance, the FDA added recommendations that manufacturers consider the unique characteristics of their device’s intended use populations (such as ethnicity, gender, and disease severity) and intended environments in their PCCP.
The FDA also newly recommends that manufacturers update a device’s labeling and public-facing documents as the device is modified. Suggested updates include detailing when modifications are implemented, describing how they were implemented, and explaining how users were informed of the modifications.
COMPONENTS OF A PCCP
The recommended structure of a PCCP remains largely unchanged from the FDA’s previous draft guidance. The FDA still recommends that three sections specifically be included:
DESCRIPTION OF MODIFICATIONS
This section of the PCCP should generally “identify the specific, planned modifications” that the manufacturer intends to apply to the device following clearance or approval. The FDA has previously suggested what information should be included, such as descriptions of the planned modifications and modes of implementation.
The FDA added to these recommendations in its final guidance, specifying that manufacturers are expected to detail the projected frequency of updates and raise effective guardrails against the range of automatic updates.
MODIFICATION PROTOCOL
The FDA recommends that the modification protocol section of the PCCP detail “the methods that will be followed when developing, validating, and implementing modifications” described in the previous section.
The final guidance recommends additional content that manufacturers should include in their PCCP submissions, such as:
IMPACT ASSESSMENT
In the impact assessment section of the PCCP, manufacturers should weigh the benefits and risks of using a PCCP for the device in question and discuss how the identified risks might be mitigated.
In its final guidance, the FDA clarifies what information should be included in a PCCP for a combination product. Relevant considerations are:
The final guidance also revises the FDA’s previous recommendations on how the impact assessment should be structured. The FDA previously suggested that elements of the impact assessment could be incorporated freely into other sections of the PCCP where relevant. Although the final guidance still allows this practice, it specifies that clear references to that information must be included in the impact assessment section itself.
APPENDICES
As part of the guidance, the FDA provides two helpful resources to aid manufacturers in navigating the PCCP drafting process. First, the FDA lists a considerable number of sample questions for manufacturers to contemplate and discuss in their PCCP submissions. Second, the guidance provides several hypothetical scenarios that describe when PCCPs might be used in lieu of new marketing submissions. These include a new reference scenario related to a combination product titled, “Optical Imaging System Co-Packaged With Imaging Drugs.”
KEY TAKEAWAYS
This final guidance provides a useful framework for manufacturers and developers to address projected modifications to AI-enabled medical devices. However, it also introduces potential implementation challenges that will require manufacturers to assess the impact of these recommendations on existing quality system processes such as design control, data management practices, risk management plans, adverse event reporting, and labeling.
Manufacturers of AI-enabled medical devices should review the final guidance in its entirety to see if PCCPs might be useful in their marketing submission process. The FDA will host a webinar to answer questions about the final guidance on January 14, 2025.
For more information on recent FDA guidance on AI in medical products, contact the authors of this article, Rachel Stauffer, James R. Ravitz (McDermott Will & Emery – Partner), Paul S. Gadiock (McDermott Will & Emery – Partner), Michael W. Ryan (McDermott Will & Emery – Partner), Jeff Weinstein (McDermott Will & Emery – Counsel), Marissa Hill Daley (McDermott Will & Emery – Associate), Karis Jackson (McDermott Will & Emery – Associate), Jae Hyun Lee (McDermott Will & Emery – Associate), and Henry Fisher (McDermott Will & Emery – Associate), or any other member of McDermott’s Food, Drug & Medical Device Regulatory Group. Additional resources are also available on McDermott’s AI in Healthcare resource center.
