Proposed Changes to FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: What you Should Know

October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy. On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices“(premarket cybersecurity guidance). This coincided with release of the FDA-supported “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” for health delivery organizations (HDOs), the announcement of two…