FDA Issues Digital Health Policies for Medical Devices
Summary
FDA issued draft guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for AI/ML-enabled Device Software Functions. The draft guidance interprets a new law authorizing Predetermined Change Control Plans (PCCPs) for medical devices. PCCPs authorized by FDA will allow medical device manufacturers to make changes to an approved or cleared device, consistent with the PCCP, which would otherwise require submission of a new application to FDA. This draft guidance provides recommendations to include in PCCPs for medical devices that feature machine learning-enabled device software functions (ML-DSFs).
Impacted Sectors
Additional Information
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