Webcast
Event Title
Webinar - Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
November 2, 2023
- Date:
- November 2, 2023
- Time:
- 1:00 PM - 2:30 PM ET
Summary
The U.S. Food and Drug Administration (FDA) will discuss the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions at this webinar.
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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 Details
Date: November 2, 2023
Time: 1:00 PM – 2:30 PM ET
Please dial in 15 minutes before the start of the call to allow time to connect.
Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1607002320?pwd=SVE2L2pZSUJScHVTUXFyUlVxZk5wUT09
Passcode: $7sX6t
Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).
The dial-in information provided below is for participants who will be joining the webinar by phone only.
- U.S. Callers Dial: 833-568-8864 (Toll Free)
- For higher quality, dial a number based on your current location:
- +1 669 254 5252 US (San Jose)
- +1 646 828 7666 US (New York)
- +1 646 964 1167 US (US Spanish Line)
- +1 415 449 4000 US (US Spanish Line)
- +1 551 285 1373 US (New Jersey)
- +1 669 216 1590 US (San Jose)
- For higher quality, dial a number based on your current location:
- International Caller Dial: Please check the international numbers available
- Webinar ID: 160 700 2320
- Passcode: 875142
Webinar Materials
After the webinar, the presentation, printable slides, and transcript will be 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.