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In this on-demand webinar, Nathan Downing, Senior Attorney at Gardner Law, PLLC, discussed the potential benefits and challenges of AI and machine learning in healthcare. He covered the FDA's review process for medical devices, emphasizing the complexities of AI-enabled devices and their regulatory challenges. Nathan outlined the importance of understanding device classification, identifying required testing, and incorporating real-world device post-market studies into the submission process. He also highlighted the need for a quality system that can account for both software and AI development. The presentation aimed to help participants understand the concept of artificial intelligence, its FDA regulation, and associated challenges. The objective was also to learn how to effectively partner with the FDA to navigate the regulatory process. The meeting addressed the rapid growth of AI-enabled devices and the potential challenges the FDA might face in understanding and regulating them. 00:00 – Introduction - About the Speaker Nathan Downing 02:49 – Objectives 09:35 – Artificial Intelligence (AI)/Machine Learning (ML) in Healthcare 14:58 – FDA Regulation of AI in Medical Devices 40:23 – FDA April 3, 2023 Draft Guidance 52:48 – AI is Complex 54:58 – How to Mitigate Device Risks 56:50 – FDA Communication Strategy and Considerations 59:57 – In Closing Summary 01:00:23 – Questions Presenter: Nathan Downing | Senior Attorney at Gardner Law, PLLC Nathan focuses his practice on FDA-regulated clients. His industry experience allows him to provide actionable legal advice on a variety of health law matters. Nathan regularly advises FDA-regulated clients on regulatory and compliance matters. He advises clients on their advertising and promotion programs, represents clients in front of the FDA on a variety of matters, and assesses industry initiatives for compliance concerns. Nathan’s extensive regulatory experience allows him to advise clients regarding a variety of medical products, including pharmaceuticals, medical devices, medical foods, and nutritional supplements.