Inside Look: FDA's Cyber Review Process for Medical Devices
FDA's Jessica Wilkerson on Agency's 'Refuse to Accept' Policy, New Cyber Guidelines
September 29, 2023
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About this episode
Medical device makers in their premarket submissions to the Food and Drug Administration under the agency's new "refuse to accept" policy for cybersecurity should pay close attention to details such as a product's software bill of materials and vulnerability management, said Jessica Wilkerson of FDA.