Guidance Finalizes FDA’s Recommendations for Premarket Submissions for Device Software Functions
June 13, 2023 at 01:25 PM EST
Newly finalized guidance from the FDA is intended to help medical device sponsors know what documentation to include in premarket submissions for the agency’s evaluation of the safety and effectiveness of device software functions.
The guidance, “Content of Premarket Submissions for Device Software Functions,” was released by the FDA June 13.
The document describes “informat... Read More
