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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. Some of the highlights of this episode include:Chris views the FDA’s recent activity around cybersecurity requirements, regulations, and laws for SaMD as a necessity because manufacturers cannot seem to self-regulate. The Protecting and Transforming Cyber Health Care Act (PATCH) will give the FDA a direct mandate to manage the cybersecurity of medical devices.However, a clause in the PATCH Act allows for cybersecurity to extend to all existing legacy medical devices—not just new devices entering the market.As medical device