On March 29, 2023 the FDA issued an updated final guidance on the Refuse to Accept (RTA) policy relating to 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.What does this mean for medical device manufacturers? Join the free webinar to hear from MedCrypt’s FDA expert Naomi Schwartz
10:00AM PT/1:00PM ET