The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...