HOFFMAN HEALTHCARE CONSULTANCY

FDA June 2023 Update – Guidance document for Content of Premarket Submissions for Device Software Functions.

This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions?

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