Final Guidance on Content of Premarket Submissions for Device Software Functions

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

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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