• Summary
• Background
• Webinar Materials

Summary

The U.S. Food and Drug Administration (FDA) discussed the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions at this webinar.

Background

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. On September 25, 2023, the FDA issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The purpose of this guidance is to provide recommendations on medical device cybersecurity considerations and what information to include in premarket submissions.

• The final guidance replaces the FDA’s guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014.

Webinar Materials

The presentation, printable slides, and transcript are available on CDRH Learn under "Specialty Technical Topics," sub-section "Digital Health.”

If you have questions about this guidance document, please contact CyberMed@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.