FDA Updates “Cybersecurity in Medical Devices” Guidance, Seeks Industry Input
The FDA issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more holistic approach to managing cybersecurity, starting in the design and development of their medical devices, and relatedly flags those documents that it recommends be developed and included in device premarket submissions.
🔒 Members Only · Cyber & AI BriefYou’ve reached the member portion of this brief.Members read the full analysis and the source documents in every Brief, six days a week.