On March 29, 2023, the FDA issued an updated final guidance on the Refuse to Accept (RTA) policy relating to the acceptance of premarket submissions. A significant change is the inclusion of cybersecurity-related documentation for medical devices with external wired and/or wireless communication interfaces, including “Cyber Devices” as defined in the newly amended FD&C Act (Section 524B). In mapping its guidance to its new statutory authority, the FDA specifies what is expected when a submission is provided to the agency for review. In this webinar, Medcrypt FDA expert Naomi Schwartz discusses how these changes and more will affect Medical Device manufacturers.
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