• Summary
• Background
• Webinar Details
• Webinar Materials

Summary

On Tuesday, April 30, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss this draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.

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Background

This draft guidance proposes updated recommendations to industry on cybersecurity considerations for cyber devices and for documentation in device premarket submissions. The Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, in its current form, remains the Agency's current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

Webinar Details

Registration is not necessary.

Date: April 30, 2024

Time: 1:00 PM - 2:00 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/1608025022?pwd=ZEw0aUlOMUVTV2k4dmVIY2hMV0VmUT09

Passcode: c5@zRd

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)
    • +1 415 449 4000 US (US Spanish Line)
• International Caller Dial: Please check the international numbers available
• Webinar ID: 160 802 5022
• Passcode: 743911

Webinar Materials

The presentation, printable slides and transcript will be available on CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health" as well.

If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at digitalhealth@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.