New Technology Increases Risks for Medical Device Manufacturers
In this article for Sedgwick, Burt Snell and Paul Cotler discuss FDA developments and medical device cybersecurity, AI, software as a medical device (SaMD) and recall risks.
"Technology has been a dominant regulatory priority for the medical device sector recently. Manufacturers, marketers, and their counsel have been waiting for new and updated FDA direction on cutting-edge topics like cybersecurity, artificial intelligence, and associated recall trends with bated anticipation."
