FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says, MedTech Insight

A long-awaited draft guidance from the US Food and Drug Administration (FDA) delineates which medical software devices will need additional documentation based on risk—but it could also mean more work for some manufacturers. In discussing the FDA’s “Content of Premarket Submissions for Device Software Functions” draft guidance, Morgan Lewis partner Dennis Gucciardo said it is “helpful in simplifying things for sponsors, but it could also mean some sponsors that previously didn’t have to provide additional documentation may be required to do just that in the future.”

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