Pathways' Pick of the Week: Final FDA Guidance on PCCPs for AI

FDA expanded the scope of its guidance on pursuing predetermined change control plans (PCCPs) for AI-enabled device software functions in a final version published this week. The highly anticipated document comes about a year-and-a-half after a draft version that addressed PCCPs for machine learning-enabled devices, a subset of AI software. The final guidance is “intended to be broadly applicable to all AI-enabled devices,” FDA states, although most PCCPs the agency has reviewed up until now incorporate machine learning. PCCPs are a means for manufacturers to gain FDA authorization for planned modifications, and steps to validate the modifications, in advance to avoid needing to go back to the agency with a new submission. FDA has so far authorized more than 40 PCCPs, many targeting planned algorithm-related updates to AI devices. The final guidance provides more details about the types of submissions that can include a PCCP—including original PMAs, most PMA supplement types, traditional and abbreviated 510(k)s, and De Novos—and about how to describe PCCPs in labeling, implementing PCCP modifications, and postmarket surveillance considerations. FDA has a second pending guidance explaining how to implement PCCPs more broadly, not just in the AI arena, for instance to update compatible devices, manufacturing procedures, or other product elements without a new submission. (See “Predetermined Change at FDA: New Modification Strategy Applied to Growing List of Devices,” Market Pathways,September 26, 2024.)

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