Lexology December 20, 2024
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
The guidance finalizes core concepts of predetermined change control plans (PCCPs), which manufacturers of artificial intelligence (AI)-enabled medical devices can leverage to avoid having to create new marketing submissions each time they wish to significantly modify their devices following 510(k) clearance, de novo authorization, or premarket approval.
In Depth
Manufacturers are generally required to submit new marketing applications to the FDA for review when a software modification could significantly alter that device’s safety and effectiveness. PCCPs are supplemental documentation that manufacturers of medical devices may include as part of typical...
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