Join Hogan Lovells for this free webinar that will guide you through the latest FDA updates impacting clinical decision support software.
As software products intended to provide advice or recommendations for clinicians have become increasingly popular and more companies (including non-traditional medical device companies) have sought to enter the space, FDA has had to rapidly evolve its approach to regulating these tools in order to balance the importance of fostering innovation with limited Agency resources and FDA’s overarching mission to protect public health and safety. In particular, FDA’s framework for regulating clinical decision support (“CDS”) software has evolved several times over the last 5 years, with the most recent guidance document (issued September 2022) providing additional clarity on the Agency’s current thinking while also appearing to bring a number of products that were not previously considered actively regulated under FDA’s oversight. Join us as we discuss the various factors and considerations at play in determining whether a CDS product is likely to be actively regulated, and recent conversations we have had with FDA on these topics.
Suzanne Levy Friedman, Counsel, Global Regulatory, Hogan Lovells
Global clients in the medical device sector call on Suzanne Levy Friedman to help them navigate key legal and business issues. Suzanne’s practice focuses primarily on matters related to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices.
Suzanne assists device companies in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for clearance/approval of new devices, advising manufacturers on the lawful promotion and advertising of their devices, and evaluating post-market product modifications. Suzanne is well-versed regarding FDA’s evolving paradigm for software and digital health products, and she has helped clients determine the appropriate regulatory pathway for, and bring to market, various products in this space. She also works with clients on internal investigations into promotional, quality system, or other issues related to compliance with the Federal Food, Drug, and Cosmetic Act.
Suzanne frequently works on human tissue and combination products that combine a medical device element with a drug or a biologic. In conjunction, she helps advise clients on regenerative medicine and cell/gene therapies, which often raise questions that touch on multiple areas of FDA regulation.
Suzanne brings significant experience in the FDA space to her work at the firm. During law school, she interned for FDA’s Office of Chief Counsel. Prior to law school, Suzanne spent two years with a health policy consulting firm in Washington, D.C., advising clients on the business impacts of FDA actions and related legislation. Suzanne also has a master’s degree in bioethics.
In law school, Suzanne co-led Penn Law’s health law and policy pro bono group, and she remains actively involved in pro bono service at Hogan Lovells.
Kelliann Payne, Partner, Global Regulatory, Hogan Lovells
Kelliann Payne’s science education and background in the medical device industry allow her to quickly understand emerging medical device technology, including digital health products, and informs her current focus on related legal and business issues. Her experience includes the development, regulation, advertising, and litigation of medical devices and digital health products, including machine learning-based clinical decision support software.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
In her role as Assistant General Counsel at QVC, Inc. from 2013 to 2014, Kelliann counseled internal clients on Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations applicable to health, wellness, beauty, and cosmetic products.
As a consultant for the medical device industry, she assisted companies with complex regulatory challenges and strategies for marketing innovative products. Kelliann majored in biology prior to pursuing a career in law.
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