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Client Alert

April 6, 2023

FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?

First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of FDA expectations for AI/ML-based SaMDs centering on the use of a “Predetermined Change Control Plan” (or PCCP) has been widely discussed by industry for years. In January 2021, FDA committed to publishing PCCP guidance in the Agency’s “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.” Further, Section 3308 of the Food and Drug Omnibus Reform Act of 2022 added Section 515C to the Federal Food, Drug, and Cosmetic Act, which granted FDA authority to approve a PCCP “submitted in an application . . . that describes planned changes that may be made to the device . . . if the device remains safe and effective without any change.”

Earlier this week, on April 3, 2023, FDA released the much-anticipated “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” draft guidance (PCCP Draft Guidance). FDA is accepting comments on the PCCP Draft Guidance until July 3, 2023 (Docket No. FDA-2022-D-2628).

Although you will see some concerns and areas needing clarification below, the publication and future implementation of this draft guidance has the potential to significantly reduce the number of regulatory submissions required for modifications to AI/ML-enabled medical devices.  The release of software updates driven by the learning capabilities of these systems may be significantly accelerated under the PCCP mechanism.


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