FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). The white paper ...
As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of ...
With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it ...
Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...
The U.S. Food and Drug Administration's latest plan for overseeing clinical decision-support software leaves too much room for interpretation over what types of software the agency intends to regulate ...
Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...
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