Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including medical devices and software as a medical device (SaMD). So, regulatory ramifications are possible with such technology and innovation.
In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA).
“SaMD is software that may be used to diagnose, prevent, monitor, or treat a disease.” Michelle Rubin-Onur
“FDA is really interested in helping develop a regulatory path for manufacturers of SaMD, and helping these devices get to market.” Michelle Rubin-Onur
“The guidance out there is fairly good. FDA is still trying to figure out how they’re going to regulate a lot of this.” Allison Komiyama
“The categorization for SaMD is independent of categorization of medical devices...because they do look at different things.” Michelle Rubin-Onur
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