Guidances with Digital Health Content
The guidance documents listed here are FDA guidances with Digital Health content and are intended to provide clarity on the FDA's regulation of digital health products.
Please note that the 21st Century Cures Act (12/13/2016) amended the definition of "device" in the Federal Food, Drug, and Cosmetic Act to exclude certain software functions from FDA regulation.
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