Small Change, Large Impact: The FDA’s Final Guidance On Premarket Submissions For SAMD/SIMD

Quality and regulatory expert Eric Henry spoke to Medtech Insight about the impact of the changes between the draft and final versions of the US FDA’s SIMD/SAMD premarket guidance document. 

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The US Food and Drug Administration’s final guidance on Content of Premarket Submissions for Device Software Functions may not differ too much from its 2021 draft, but the small changes may have a large impact.

Eric Henry, senior quality and regulatory compliance advisor at King and Spalding, spoke to Medtech Insight about

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