Laurie A. Clarke, AB, MPP, JD

Vice President and Principal, Medical Device Regulatory

Contact

+1 202 828 8975 laurie.clarke@tsgconsulting.com

Laurie Clarke leads TSG Consulting’s medical device regulatory practice. Her knowledge and experience as a former FDA lawyer enable her to be an effective adviser and advocate for clients throughout the device lifecycle.

Laurie specializes in helping device companies develop and implement regulatory strategies that meet their marketing objectives. A former FDA partner at three top-ranked law firms, Laurie is a recognized leader in medical device regulations, spanning from premarket submissions to FDA enforcement actions.

Throughout her career, Laurie has assisted clients with 510(k) premarket notifications, investigational device exemptions (IDE), premarket approval applications (PMA), de novo review submissions, pre-submissions, requests for designation of combination products as devices, and 513(g) requests. She has extensive experience preparing clients for FDA meetings, as well as representing them at such meetings. Laurie has a proven track record of obtaining FDA clearance or approval to market and conduct clinical (human) testing of a wide range of medical devices. In addition, Laurie has helped companies register their establishments, list their devices,  and evaluate modifications to marketed products.  She has also helped device manufacturers prepare for FDA inspections, comply with medical device reporting requirements, promote their products without making off-label claims, and conduct recalls.

Prior to joining TSG Consulting, Laurie was Executive Vice President of Medical Devices & Combination Products at Greenleaf Health. She has also been an FDA partner at Jones Day, King & Spalding and Hogan & Hartson, all international law firms with top medical device practices.  She started her career as an FDA lawyer at Patton, Boggs, and Blow, a law firm that combined legal representation with lobbying for policy changes.

Laurie earned a JD from Stanford University, an MPP with a concentration in Health Policy from Harvard University, and an AB cum laude from Smith College.

Professional Memberships

District of Columbia Bar Association, Member

Massachusetts Bar Association, Member

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