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Content of Premarket Submissions for Device Software Functions

Updated: Jul 4, 2023

The FDA just published draft guidance on Premarket Submissions for Device Software Functions. It describes the information the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both SaMD and SiMD. This draft guidance will provide clarity, simplicity and harmonization with current best practices and recognized voluntary consensus standards, once finalized:

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Software medical device
Software medical device

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