In part one of this two-part special episode, Mike welcomes Suzanne Schwartz, Director of the Office of Strategic Partnerships and Technology Innovation (OST) at FDA’s Center for Devices & Radiological Health (CDRH) and Kevin Fu, Acting Director of Medical Device Cybersecurity at FDA’s Center for Devices and Radiological Health (CDRH) and Program Director for Cybersecurity. Join us as they talk about the FDA'S journey to designing cybersecurity standards for medical devices including establishing pre and post-market policy, threat modeling and SBOMs (Software Bill of Materials).

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