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On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in...
Digital health data can facilitate the participation of underrepresented and diverse patient populations in clinical trials, but first the FDA must build its capability to evaluate such information in its regulatory processes for new drug development.
This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the...
Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and...
12/16/22 Clinical Leader Newsletter