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 The documents offer: a framework for the use of digital health tools in the context of drug development; draft guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI)/machine learning (ML)-enabled device software; and final guidance issuing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 on modernizing its approach to digital health technology (DHT) derived data in clinical drug development. Note that this initiative is not directly related to the regulation of digital health medical devices, although DHTs used for deriving data for drug development may also constitute regulated medical devices.
Key Takeaways
The Framework outlines a multifaceted DHT strategy that will include both internal programs to support DHT-related activities within the FDA and external programs to engage industry stakeholders in the development and use of DHTs. Specifically, the FDA has established a DHT Steering Committee consisting of members from the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Oncology Center of Excellence (OCE), the Office of the Commissioner, and the Center for Devices and Radiological Health (CDRH) and its Digital Health Center of Excellence (DHCoE) to support the implementation of the Framework.
The Framework outlines programs aimed at buildin ..
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