Also issued today was the final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act which addresses other digital health provisions included in the Cures Act. Specifically, this final guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices under the amended definition of device. We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.

The digital health technologies described in this guidance (3060) have been previously discussed in existing medical software guidances. That’s why today we are also updating four previously issued FDA final guidances to align with interpretations and policies under the Cures Act: Final Guidance on Policy for Device Software Functions and Mobile Medical Applications; Final Guidance on General Wellness: Policy for Low Risk Devices; Final Guidance on Off-The-Shelf Software Use in Medical Devices; Final Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. Changes to these documents include clarification that many products previously under enforcement discretion no longer are medical devices under the 21st Century Cures Act, and therefore are not subject to FDA’s regulations and oversight.


Overall, these important guidance documents being issued today expand on our efforts to both encourage innovation in the ever-changing field of digital health and protect the public health. Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation according to the Cures Act. These documents are critical elements of FDA’s comprehensive approach to digital health. We are committed to promoting beneficial innovation in this space while providing appropriate oversight where it’s merited.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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