Division of Clinical Research

Office of the Vice President and Innovation

Category results for: wellness devices

Recently Posted FDA Guidance Documents

9/27/2019 –¬†Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]

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