It is encouraging to see the FDA’s Center for Devices and Radiological Health (CDRH) has signaled in their proposed guidances for fiscal year 2024 (FY2024) that guidances related to Artificial Intelligence/Machine Learning (AI/ML) are getting a high priority from the Agency. The draft guidance issued on April 3, 2023 titled “Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”, which was previously discussed in a DHC post here, has been assigned to the “A-list” priority for final guidance publishing in FY2024. While this movement may seem glacial to some, it is quite uncommon to have a draft guidance issue as a final guidance within 18 months of first draft issuance. This signals the FDA is taking AI/ML as a high priority issue regarding the impacts it has on medical devices, and recent clearances are demonstrating an uptick in predetermined change control plan (PCCP) inclusion, showing industry has taken notice of this opportunity afforded in PCCP.
Further AI/ML interest at FDA was signaled by the “A-list” priority intent to issue a draft guidance titled “Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations.” The publishing of this draft is eagerly awaited by those in industry to help meet the FDA’s expectations on AI/ML, which should help industry in preparing AI/ML involved marketing submissions for FDA review and hopefully accelerate the entire process for all parties involved.
As a final note, the FDA published today an updated list of AI/ML enabled devices, adding 171 cleared devices to this list. The vast majority of devices on this list were cleared by the Radiology division at FDA, but a number of other divisions at FDA did see some involvement. There is reason for optimism that the issuance of final and draft AI/ML guidances will only increase those clearance numbers overall and create greater opportunities for a greater diversity of participants in the AI/ML device space.
