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Content of Premarket Submissions for Device Software Functions (FDA, Jun 2023)

FDA

Content of Premarket Submissions for Device Software Functions (FDA, Jun 2023)

FDA guidance on the software documentation to include in a premarket submission, by documentation level.

June 1, 2023

Published

FDA

Source

Topic

https://cdn.prod.website-files.com/5f10960649ee0832d2b92042/68ed501e0da7810360ba0d7f_PFDA%20Guidance%20-Premarket-Software-Functions-Guidance%20-June%202023.pdf

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