OMB Approves FDA Medical Device Cybersecurity Guidance

Yesterday, OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved the publication of a draft guidance document for industry and the FDA Administrative Staff on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. As is typical for guidance documents, there was no listing for this in the Fall 2021 Unified Agenda. The document was submitted to OIRA on March 11^th, 2022.