FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

Lexology October 8, 2019
Mintz

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following:

• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (“Section 3060 Changes Guidance”) – Final
• Policy for Device Software Functions and Mobile Medical Applications (“MMA Guidance”) – Final
• General Wellness: Policy for Low Risk Devices (“General Wellness Guidance”) – Final
• Off-The-Shelf Software Use in Medical Devices (“OTS Software Guidance”) – Final
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (“MDDS Guidance”) – Final
• Clinical Decision Support Software (“CDS Guidance”) – Draft

In addition to the expected changes, FDA also made significant substantive changes to the Clinical Decision Support Software...

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