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ARTICLE · 18 DECEMBER 2024

FDA Publishes Final Predetermined Change Control Plan Guidance For AI-Enabled Device Software Functions

King & Spalding
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On December 4, 2024, FDA finalized its guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan...

United StatesFood, Drugs, Healthcare, Life Sciences
Jessica Ringel
Jessica Ringel
Lisa M. Dwyer
Lisa M. Dwyer
Eric Henry
Eric Henry
McKenzie Cato
McKenzie Cato

On December 4, 2024, FDA finalized its guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions" (the "2024 Final Guidance"). The Final Guidance replaces the Draft Guidance issued in April 2023 (the "2023 Draft Guidance").

The 2024 Final Guidance is largely consistent with the 2023 Draft Guidance but has some notable changes, as discussed below. Please see our Client Alert on the 2023 Draft Guidance for a detailed overview of FDA's current thinking on Predetermined Change Control Plans (PCCPs) for artificial intelligence (AI)-enabled device software functions outside of the changes discussed here. We also note that that some of the process-related changes appear to bring the 2024 Final Guidance into alignment with FDA's Predetermined Change Control Plans for Medical Devices Draft Guidance published August 22, 2024, which applies the concept of PCCPs to

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