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A Walk Through FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance

May 22 @ 12:00 pm - 1:00 pm

In April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance, and FDA has been actively reviewing PCCPs in submission prior to and since the publication of this document. This session will walk through the contents of the draft guidance highlighting specific recommendations, implications to industry and FDA, and how this guidance might help or hinder an effective regulatory framework for incorporating AI/ML functionality into medical devices.

Details

Date:
May 22
Time:
12:00 pm - 1:00 pm
Event Category: