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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