Lexology April 4, 2024
Fenwick & West LLP

What You Need to Know:

  • Wondering how the FDA will regulate your digital health or software product? A new navigator tool can help determine the FDA’s potential oversight.
  • An FAQ page offers resources for quickly finding the FDA’s guidance on various digital health policy topics.
  • There are also several methods for obtaining formal and informal advice directly from regulators.

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its division of digital health into a full-fledged center of excellence (DHCoE), and the DHCoE has since been actively updating its resources to keep medical device developers informed regarding the FDA’s thinking and...

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Topics: Digital Health, FDA, Govt Agencies, Regulations, Technology
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