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The “Content of Premarket Submissions for Device Software Functions” draft guidance would regulate software as a medical device (SaMD) and software in a medical device (SiMD).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