FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control Plan in marketing submissions for intended modifications of artificial intelligence ("AI")-enabled devices.
On December 3, 2024, FDA issued final guidance that outlines FDA's recommendations on the content of a marketing submission for a Predetermined Change Control Plan—a plan outlining a change that a manufacturer will implement—for medical devices that include one or more AI software function(s). Because the agency recognizes that medical devices that incorporate AI are continuously building, testing, and learning, FDA will review these plans "to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions" for changes that are inherent in devices that incorporate AI. Once a Predetermined Change Control Plan is approved, manufacturers can implement post-market modifications that are specified in and implemented in accordance with the authorized plan without seeking additional FDA authorizations. The modification and analysis should be well documented in accordance with FDA requirements.
While substantially similar to the 2023 draft guidance, the final guidance has certain notable differences, including an expanded scope to apply to AI-enabled devices broadly, a new section on version control and maintenance, further discussion on content requirements and updated labeling, and a new example addressing a post-authorization modification scenario.
Predetermined Change Control Plans for medical devices that incorporate AI have three main components:
- Description of Modifications. Describes the specific, planned modifications, and rationale for the change. For efficient review, plans submitted should include a limited number of specific modifications that can be verified and validated.
- Modification Protocol. Details the methods that will be followed when developing, validating, and implementing modifications. For each modification, data management practices, re-training practices, performance evaluation protocols, and update procedures must be addressed.
- Impact Assessment. Documents the benefits and risks of implementing the planned modifications, and the impact to the AI software function and overall device functionality.
FDA encourages manufacturers to engage with the relevant review division early in the pre-submission process regarding a proposed Predetermined Change Control Plan to get FDA's feedback on, for example, whether the scope of the modifications is appropriate for such a plan.
FDA will host a webinar to answer questions about the final guidance on January 14, 2025.
