Noteworthy Changes From FDA's Latest Software Guidance
Law360 (November 8, 2019, 6:18 PM EST) -- The U.S. Food and Drug Administration recently released six pieces of software-related guidance, advancing the agency’s Digital Health Innovation Action Plan:
Clinical Decision Support Software;
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act;
Policy for Device Software Functions and Mobile Medical Applications;
General Wellness: Policy for Low-Risk Devices;
Off-The-Shelf Software Use in Medical Devices; and
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.
Altogether, the guidance makes a variety of technical changes and clarifications to the FDA’s interpretation of the 21st Century Cures Act exemptions for certain software...
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