WebSoftware as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device Working Group in the IMDRF SaMD WG N10 / Software as a Medical … WebYeah. So the FDA recently came out with a guidance on the use of CDS software in September of 2024. This is in response to a law, particularly the Cures Act, which dictated how to define software as a medical device. So the FDA, despite being called the Food and Drug Administration, no longer regulates only food and drugs; it also regulates ...
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