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  4. Webinar - Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations - 02/18/2025
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Webcast | Virtual

Event Title
Webinar - Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
February 18, 2025

Date:
February 18, 2025
Time:
2:00 p.m. - 3:30 p.m. ET

Summary

On February 18, 2025, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss the draft guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.

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Background

The draft guidance includes lifecycle considerations for AI-enabled devices, as well as specific recommendations to support marketing submissions for these devices.

The draft guidance, when finalized, is intended to :

  • Recommend the documentation and information to include in a marketing submission to the FDA if a device has one or more AI-enabled software functions.
  • Support a Total Product Life Cycle (TPLC) approach to the management of AI-enabled devices, including providing recommendations for the design, development, and maintenance of AI-enabled devices.
  • Help sponsors of AI-enabled devices to identify other relevant guidances to assist them with applying the recommendations in those guidances to AI-enabled devices and support activities throughout the lifecycle of the device.

Webinar Details

Registration is not necessary.

Date: February 18, 2025

Time: 2:00 - 3:30 p.m. ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Meeting Link: https://fda.zoomgov.com/j/1610719212?pwd=Qnh0czY3T2ZVUS9Gdy90d1c1R09WUT09 

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
      • +1 669 216 1590 US (San Jose)
  • International Caller Dial: Please check the international numbers available
  • Webinar ID: 161 071 9212
  • Passcode: 692934

Webinar Materials

Following this webinar, the presentation and transcript will be available on CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health" as well.

If you have questions about this draft 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.

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