A Walk Through FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance

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Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance, and FDA has been actively reviewing...

RAPS Convergence

More information to come - dates and topics subject to change.