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Today the U.S. Food and Drug Administration (FDA) issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions. The guidance replaces the FDA’s guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014.
The increased integration of wireless devices, electronic exchange of medical device-related information, and cybersecurity vulnerabilities and incidents, highlight the importance of having stronger cybersecurity measures. This final guidance provides recommendations about medical device cybersecurity considerations and information to include in premarket submissions.
Upcoming webinar on this guidance
On November 2, 2023, the FDA will host a webinar for industry and other stakeholders interested in learning more about this guidance.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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