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Medmarc Blog (blog.medmarc.com)

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Machine Learning

Regulatory Partners Release guidelines for PCCPs

January 29, 2024

The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...

AdvaMed and CapView Propose Plan for Medicare Coverage of AI

September 25, 2023

The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...

FDA Seeks Feedback on AI in Drug Development, Manufacturing

May 23, 2023

The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...