New FDA Digital Health Final Guidances Signaling Deregulatory Approach: General Wellness Devices, CDS Software

As a nationally recognized member of the firm’s FDA regulatory team, Mr. Diamond focuses his practice exclusively on federal and international legal matters for businesses and products regulated by the FDA, and similar regulators in other major international markets. His regulatory practice spans research, commercialization, post-market compliance, marketing and promotion, and enforcement across all FDA-regulated products, with a primary focus on drugs, devices, and diagnostics (including digital health products). Mr. Diamond regularly counsels clients on “high-stakes” interactions with FDA, especially involving enforcement actions. His background as a trained bioethicist, combined with his experience teaching bioethics at leading academic institutions, enhances his ability to assist companies with ethical considerations that can emerge during research and product commercialization. Since 2018, Mr. Diamond has taught as an adjunct professor at the Georgetown University Law Center. He is also an accomplished writer whose work has been featured in leading law reviews, scholarly journals, and well-respected media publications worldwide.

Ms. 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. Ms. Payne 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. Ms. Payne is a Fortner Assistant General Counsel at QVC where she counseled internal clients on FDA and FTC regulations applicable to health, wellness, beauty, and cosmetic products.

Ms. Ravitz focuses on matters before the FDA, counseling U.S. and international life science, healthtech and consumer product clients through all phases of the product lifecycle including strategic pre-market regulatory counseling, promotions and advertising, and post-market regulatory compliance. She also has extensive experience in assisting clients with product recalls, crisis management and government enforcement. Her practice in this sector includes assisting manufacturers, distributors, retailers and importers on all types of FDA regulated products including pharmaceuticals, medical devices and software, wearables, health and wellness products, cosmetics, cell and plant-based foods, conventional foods, ag tech, compounded drugs, and dietary supplements. Ms. Ravitz’ deep experience and ability to provide practical guidance in FDA and FDA-adjacent regulatory matters allows her to work closely with innovative companies looking to minimize regulatory burdens and maximize U.S. marketing opportunities in the life science and health tech industry verticals. She also conducts regulatory due diligence for private equity and public company transactions involving life science, medtech and innovative companies. Ms. Ravitz is a frequent speaker at conferences and events who contributes regularly to leading trade and consumer media outlets.