FDA Sends Medical Device Cybersecurity Guidance to OMB

On Friday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a notice from the FDA on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff”. This guidance document was not listed in the Fall 2021 Unified Agenda (guidance documents are not typically listed there), but this looks like it may be an update of the 2018 Draft Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.