Lexology April 4, 2023
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug development; draft guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI)/machine learning (ML)-enabled device software; and final guidance issuing cybersecurity requirements for device authorization submissions.
Using Digital Health Technologies in Drug Development
On March 23, 2023, as part of its commitment under the Prescription Drug User Fee Act (PDUFA VII), the FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (the “Framework”). The Framework is part of the agency’s ongoing effort to focus...
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