MWSQA Webinar: FDA Artificial Intelligence Guidances: Industry Responses In-Depth Review

This online webinar will be given via Zoom.

In January 2025, the U.S. Food and Drug Administration released two draft guidances that mark a significant step in shaping the regulatory future of Artificial Intelligence in the life sciences industry:

•     Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft Guidance for Industry and FDA Staff)
      
•    Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products (Draft Guidance for Industry and Other Interested Parties)
  

This webinar will begin with a clear overview of both guidances, including their scope, applications, and key regulatory expectations for AI-enabled technologies across medical device and drug/biologic product domains. In the second half, presenters will share a curated summary of the public comments and feedback submitted to the FDA by stakeholders during the open comment period. Attendees will gain insight into emerging industry perspectives on AI transparency, performance monitoring, regulatory risk, and implementation challenges. The session will conclude with a Q&A roundtable to discuss implications for compliance strategies and future regulatory planning.

Even though this event is complimentary for members, you must continue to checkout to complete your registration.  After registering, you will receive further instructions on how to access the webinar via email in 1-2 business days.