Device software function (DSF)

FDA reviews device software by function, so a product can have device and non-device functions. Documentation level in a submission depends on the risk of the device software function.

Software function that meets the device definition in section 201(h) of the FD&C Act. As discussed above, the term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.

FDA guidance: Content of Premarket Submissions for Device Software Functions (June 2023), Section IV, Definitions

A software function that meets the device definition in section 201(h) of the FD&C Act. As discussed in other FDA guidance, the term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Section IV, Definitions