Pathways' Pick of the Week: Predetermined Change Guide Coming

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FDA's predetermined change control plan draft guidance for AI/ML devices is almost out. Excerpted from Pathways' Picks February 22: EMA Pilot, China UDI, FDA AI Guide.

FDA staff has finished work on a long-anticipated draft guidance document outlining the use of predetermined change control plans (PCCPs) for artificial intelligence/machine learning (AI/ML) software. It is likely to be issued for public review in the coming weeks after the White House Office of Management and Budget (OMB) completes its oversight. PCCPs, first proposed by FDA in 2019, are intended to address the challenge of adaptive AI/ML, where it would be a challenge to go back to FDA for modification reviews when the software undergoes anticipated algorithm updates. They allow a manufacturer and FDA to agree on anticipated post-approval product updates as part of premarket review. PCCPs are already being employed on a limited basis by FDA. Congress recently passed a bill providing FDA with more explicit authority for PCCPs, which could help expand application to more types of submissions, even beyond the AI/ML area. (See “Change Control Plans to Avoid New FDA Submissions Get Support in Senate,” Market Pathways, June 21, 2022.)


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