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Guidances with Digital Health Content

The guidance documents listed here are FDA guidances with Digital Health content and are intended to help industry and FDA staff understand FDA's regulation of digital health products.

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in the guidance documents below.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

List of FDA Guidance Documents with Digital Health Content


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