This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005, and updates FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.
The recommendations in this guidance are intended to facilitate FDA’s premarket review. This guidance describes information that would be typically generated and documented during software development, verification, and 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 premarket review, FDA may request additional information that is needed to evaluate the submission.