On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.” This update represents a key advancement in the FDA’s regulatory framework, designed to support continuous innovation in AI-enabled medical devices while maintaining their safety and effectiveness.
The guidance introduces the concept of a Predetermined Change Control Plan (PCCP), which details planned modifications to AI-enabled devices. The PCCP includes methodologies for development, validation, and implementation of these changes, as well as assessments of their impact on the device’s safety and effectiveness.
主要亮点：
- Scope of Application:
The guidance applies to AI-enabled devices across various product categories, including those reviewed under the 510(k) premarket notification, De Novo classification request, and Premarket Approval (PMA) pathways. It also encompasses device components of device-led combination products. - Review Process:
The FDA will evaluate the PCCP as part of the device’s marketing submission, ensuring that planned modifications comply with safety and effectiveness standards. This eliminates the need for new marketing submissions for every modification listed within the PCCP. - Public Comments and Updates:
Revisions to the guidance reflect feedback from public comments, including clarifications on scope, labeling requirements, implementation processes under an authorized PCCP, and postmarket surveillance recommendations. Definitions of “artificial intelligence” and “machine learning” were updated to align with Executive Order 14110 issued on October 30, 2023.
This guidance marks a milestone in regulatory practices for AI-enabled devices, balancing innovation with public health priorities.
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