FDA Issues PCCP Guidance for AI Medical Devices

The FDA has issued an official guidance (December 2024), related to AI enabled device software marketing submissions and PCCP (Predetermined Change Control Plan) process. AI technology is innovative and requires constant updates to ensure the information or data produced by the AI technology is accurate and provides the users with the information needed to continue to advance healthcare and improve patient outcomes.

FDA AI Device Software: Key Recommendations for PCCP Modifications

The FDA guidance provides recommendations for devices with AI software on the information to include in the Predetermined Change Control Plan (PCCP). The PCCP is used to describe planned device modifications and is reviewed by the FDA as part of the marketing submission process. The PCCP includes details related to the methodology for development, validation and implementation of these planned modifications along with a detailed assessment of the potential impact these modifications could cause.

The goal of the recommendations is to help reduce the need for additional marketing submissions as a result of the modifications described in the PCCP.

The guidance can be viewed at:  Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions | FDA.

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This FDA guidance streamlines regulatory processes for AI-enabled devices by outlining clear expectations for planned modifications through the PCCP, supporting innovation while ensuring safety and effectiveness. For more details or assistance with compliance, contact us today.

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