FDA Issues Revised Cybersecurity Premarket Submission Guidance To Align With Quality Management System Regulation

The United States Food and Drug Administration (FDA) has released updated cybersecurity guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff (Guidance), reflecting the agency’s response to the growing integration of wireless and network connected capabilities in medical devices, which has made cybersecurity controls central to device safety and effectiveness.... By: DLA Piper