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Validity : 04th May'25 to 14th May'25
US FDA Artificial Intelligence - Machine Learning Framework
- AI / ML and the FDA’s “Framework”.
- “Locked” vs “Adaptive” AI
- AI software’s "predetermined change control plan"
- Expected AI deliverables
- FDA AI device submission requirements
- Suggested AI V&V “model”
- AI’s regulatory future.
Overview of the webinar
The ability of artificial intelligence/machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and risks and has started to outline its expectations of industry and device design, programming, unique validation issues, documentation, and submissions under a new “AI Framework”. These changes and new expectations for AI development, documentation, and submissions to the Agency will be discussed.
Who should attend?
- Sr. Management
- R&D
- Software Engineering
- QA/RA
- Marketing
Why should you attend?
The US FDA has announced steps toward a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence/machine learning algorithms. Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. The FDA has already authorized some AI-driven devices. The authorization of these technologies was a harbinger of progress that the FDA expects to see as more medical devices incorporate advanced artificial intelligence algorithms to improve their performance and safety. AI software validation and submission requirements have some major new FDA requirements as well, a major one being how to address the evolving nature of the device over time without having to refile submissions. The Agency plans to apply its current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.