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

A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some manufacturers.

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The US Food and Drug Administration on 3 November published a draft medical software guidance that would require certain products to show extra documentation based on two distinct categories defined by a product’s risk level. While the document attempts to simplify and update current regulations, it could also mean more work for some companies.

The “Content of Premarket Submissions for Device Software Functions” draft guidance would regulate software as a medical device (SaMD) and software in a medical device (SiMD). Based on four...

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