FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the recent rise of AI, FDA published two hotly anticipated communications, one pertaining to medical devices and the other to drug manufacturing. Please join AGG Technology chair Lori L. Wright and AGG Food & Drug attorney Laura S. Dona for a complimentary webinar as they examine how the agency is trying to keep up in a world where data and information are quickly evolving. AGG Food & Drug co-chair Alan G. Minsk will serve as moderator.

During the webinar, Lori, Laura, and Alan will discuss:

• FDA’s draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”;
• FDA’s discussion paper, “Artificial Intelligence in Drug Manufacturing”; and
• their observations and insights for industry.

There will be an opportunity for Q&A at the end of this webinar.

Credit: 1 hour of CLE credit pending approval by the State Bar of Georgia.