Webinar: The FDA ‘Cybersecurity Refuse to Accept Policy’ will affect Medical Device Manufacturers!

Описание к видео Webinar: The FDA ‘Cybersecurity Refuse to Accept Policy’ will affect Medical Device Manufacturers!

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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