FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions. This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions.
The guidance replaces the FDA’s Guidance for the 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 risk-based approach to the documentation the FDA recommends sponsors include for the review of device software functions in premarket submissions.
Download the guidance here: 2023-Premarket-Software-Functions-Guidance-Final
