Lexology April 4, 2023
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI)/machine learning (ML)-enabled device software, and final guidance issuing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. Another document is a framework addressing the use of digital health tools in the context of drug development. The comment periods for the digital health technologies framework and the draft guidance for AI/ML-enabled device software end on May 23, 2023, and July 3, 2023, respectively.
Using Digital Health Technologies in Drug Development
On March 23, 2023, as part of its commitment under the Prescription Drug...
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