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Draft Guidance for Device Software in Premarket Submissions - USFDA

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The recommendations in this guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD).

“Software in a Medical Device” (SiMD)—defined as software that is a part of a medical device or controls it—and “Software as a Medical Device” (SaMD), which is software that meets the definition of a device but is not part of the overall device’s hardware.

Both SaMD and SiMD are “device software functions,” according to the agency.

This guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in this guidance also may help facilitate FDA’s premarket review.

This guidance describes the information that would be typically generated and documented during software development, verification, and design validation.

The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses software. During the premarket review, FDA may request additional information that is needed to evaluate the submission.

Check out this guidance for more detailed information.


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