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Inside the FDA's Emerging Framework for Generative AI-Enabled Medical Devices
WSGR Events
Tuesday, September 29, 2026
11:00 - 11:30 a.m. PT

Virtual

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On August 18, 2026, the U.S. Food and Drug Administration (FDA) offered new insight into how it may approach the regulation of generative AI-enabled medical devices: a two-axis risk framework and a competency-based evaluation model spanning benchmarking, clinical confirmation, and post market monitoring. As we detailed in our recent client alert, the agency is seeking comments through October 19, 2026, a narrow window to shape policy while the framework is still taking form.

Join Wilson Sonsini partners Jodi Daniel and Eva Yin and Of Counsel Ty Kayam, who previously served as the first attorney in the FDA's Digital Health Center of Excellence, for a focused session on what the discussion paper means for developers, sponsors, and platform providers; the open questions the FDA is asking stakeholders to answer; and how to submit an effective comment before the deadline.

Contacts

Adam Pilkington

apilkington@wsgr.com

Presenters

Jodi Daniel
Partner
Washington, D.C.

Jodi Daniel is a nationally recognized leader in digital health law and policy, trusted by health care organizations and technology innovators to navigate the complex and dynamic regulatory landscape of digital health and wellness. With over 30 years of experience in healthcare innovation—including 15 years as a lawyer and senior policymaker at the U.S. Department of Health and Human Services (HHS)—Jodi leverages her extensive experience in digital health and health data to deliver strategic, practical advice to clients engaged in groundbreaking products and services that raise novel legal, policy, and ethical issues.

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Eva F. Yin
Partner
Seattle

Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.

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Ty Kayam
Of Counsel
Seattle

Ty Kayam is Of Counsel in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she advises companies and investors on regulatory strategy for health technology products, with a particular focus on health AI, digital health, wearables, medical robotics, and health data infrastructure. She counsels clients throughout product development and commercialization and advises on health regulatory issues arising in financings, investments, partnerships, and strategic transactions. Her practice draws on experience at the FDA, Microsoft, and a national health information network, combining regulatory insight, technical fluency, and a systems-level understanding of how health technologies are developed, deployed, and scaled.

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