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Month: December 2022

Last Updated on June 15, 2023
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Posted in BLOG, FDA Updates
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Leave a Comment on New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

By - SebastianFeye

New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

Medical Device software continues to evolve and change as do FDA regulations. When it comes to the content of the software documentation requirements for a pre-market submission (510k), the FDA’s last issued guidance back in 2005. However, on June 14 2023, FDA released a new and revised final guidance document which substantially alters software requirements for 510k submissions by changing

Tagged : 510(k), 510k, FDA, Guidance, Medical Devices, SAMD, Software, Specifications, SRS