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  5. Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - 01/14/2025
  1. CDRHNew - News and Updates

Webcast | Virtual

Event Title
Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
January 14, 2025

Date:
January 14, 2025
Time:
2:00 p.m. - 3:15 p.m. ET

Summary

On January 14, 2025, the FDA will host a webinar for industry and other interested stakeholders to answer questions about the final guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.

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Background

This guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.

This guidance is part of the FDA’s broader commitment to develop and apply innovative approaches to the regulation of device software functions and proposes an approach that would often be least burdensome for manufacturers to support iterative improvement through modifications to an AI-DSF while continuing to provide a reasonable assurance of device safety and effectiveness.

Webinar Details

Registration is not necessary.

Date: January 14, 2025  

Time: 2:00 P.M. – 3:15 P.M. 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/1612785349?pwd=dTNCbFkvZm5wbGJEOGt1WHFrRytSdz09 

Passcode:  g=@0XS

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: 161 278 5349
  • Passcode: 598428

Webinar Materials

The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under "Specialty Technical Topics”, sub-section “Digital Health." 

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.

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