April 10, 2023
Top News
FDA Draft Guidance on AI-/ML-based Software
Recently, the FDA released a draft guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The FDA will hold a webinar on this draft guidance on April 13. Comments due July 3.
Administration
CMS Summary of "Make Your Voice Heard" RFI: Reducing Burden & Increasing Efficiencies
The Centers for Medicare and Medicaid Services (CMS) released a summary of results from its Make Your Voice Heard Request for Information. Check out the details.
Digital Health Technologies Framework
The FDA issued
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