Laurie Clarke is a partner in the firm’s Washington, D.C., office. Ms. Clarke’s practice focuses primarily on the Food and Drug Administration’s (FDA) regulation of medical devices. She specializes in premarket submissions, including 510(k) premarket notifications, investigational device exemption (IDE) applications, pre-IDE submissions, premarket approval (PMA) applications, amendments, and supplements, reclassification petitions, de novo review submissions, device designation requests for combination products, and requests for humanitarian use designation. In addition, Ms. Clarke has extensive experience counseling medical device manufacturers and tissue processors regarding compliance with FDA laws and regulations, including labeling requirements. She is an expert on FDA’s policies regarding disclosure of clinical investigators’ financial interests in devices being tested in humans. Ms. Clarke has assisted clients in developing successful regulatory strategies for a wide variety of medical devices, including cardiac, general surgery, obstetrics/gynecology, anesthesiology, respiratory, gastroenterology, renal, urology, radiology, physical medicine, dental, ophthalmic, otolaryngology, infection control, and general hospital devices. She has represented clients ranging from small start-up companies to multi-national corporations on a broad spectrum of medical device issues. She is a member of the firm’s FDA & Life Sciences Practice Group.
Ms. Clarke was a partner at Hogan & Hartson L.L.P. in Washington, D.C., before joining King & Spalding in 2005. She practiced FDA law, with an emphasis on medical device regulation, during her 11 years at that firm. Ms. Clarke managed large and complex PMA applications and 510(k) notices containing clinical data. In addition, she developed and implemented creative substantial equivalence arguments for devices for which there were no clear predicate devices. Ms. Clarke obtained FDA clearance or approval for virtually all of the devices for which she served as regulatory counsel, including many devices that FDA had previously rejected or for which the Agency had issued major deficiency letters before she represented their manufacturers. She received a unanimous recommendation for approval from FDA’s panel of outside medical, ethics, and statistical experts for a client’s product to regrow bone even though the clinical data was equivocal. Ms. Clarke negotiated favorable indications for many clients’ devices, including devices for which their competitors’ devices had much more limited indications. She obtained medical device designations for device/drug and device/biologic combination products, determinations that products were not medical devices subject to FDA regulations, exemptions from 510(k) requirements for devices that were not explicitly exempt, and decisions that the 510(k) (rather than the PMA) route is the appropriate regulatory path for new devices for which there were no good predicate devices, expedited review for Class III devices, de novo downclassification for novel devices, and reclassification of PMA devices.
Ms. Clarke began her legal career in 1990 at the Washington, D.C., firm that was then called Patton, Boggs, and Blow. She practiced FDA law at that firm. Ms. Clarke worked on a broad range of food, drug, and device issues. In addition, she negotiated an agreement with the publisher of the Nancy Drew series to include an acknowledgement in the books that her client wrote the original stories under the pen name “Carolyn Keene”.
Ms. Clarke is the co-author of “The Medical Device Approval Process” in the Food and Drug Law Institute’s (FDLI) Practical Guide to Food and Drug Law and Regulation (2d ed.). In addition, she is the co-author of “Medical Devices: The Obvious, the Readily-Accepted, and the Surprising,”J. Health & Life Sci. L., Vol. 1, No. 4, p. 117-144 (2008). Ms. Clarke is the second author of “Splitting Hairs: A Case Study of a Substantial Equivalence Determination” in FDLI's Update, p. 40-43 (July/August 2007). She drafted the chapter entitled “The 510(k) Premarket Notification Process” in Medical Device Development: A Regulatory Overview (1st and 2nd eds.). Ms. Clarke also drafted the chapter entitled “Electronic Products” in A Guide to Medical Device Regulation.
Ms. Clarke has represented numerous clients at meetings with FDA, as well as at FDA Advisory Committee meetings. In addition, she has presented testimony at public meetings held by FDA on several topics. Ms. Clarke has served, along with FDA officials and companies’ regulatory affairs, quality assurance, and clinical personnel, on an FDLI panel regarding special and abbreviated 510(k) premarket notifications. She has jointly hosted seminars conducted by the Advanced Medical Technologies Association (AdvaMed), which is the largest trade association of medical device manufacturers. Ms. Clarke has conducted in-house training sessions for clients’ legal, regulatory, clinical, and marketing staff regarding FDA’s regulation of medical devices.
Ms. Clarke graduated, cum laude, from Smith College, with a major in government and a minor in economics, in 1985. She received her Master of Public Policy degree, with a concentration in health policy, from Harvard University’s John F. Kennedy School of Government in 1987. In 1990, Ms. Clarke graduated from Stanford Law School, where she served as an associate editor of the Stanford Law Review.
Ms. Clarke is a member of the District of Columbia and Massachusetts Bars.
- Co-author, “The Medical Device Approval Process” in the Food and Drug Law Institute’s (FDLI) Practical Guide to Food and Drug Law and Regulation (2d ed.).
- Co-author, “Medical Devices: The Obvious, the Readily-Accepted, and the Surprising,”J. Health & Life Sci. L., Vol. 1, No. 4, p. 117-144 (2008).
- Second author, “Splitting Hairs: A Case Study of a Substantial Equivalence Determination” in FDLI's Update, p. 40-43 (July/August 2007)
- Chapter author, “The 510(k) Premarket Notification Process” in Medical Device Development: A Regulatory Overview (1st and 2nd eds.)
- Chapter author, “Electronic Products” in A Guide to Medical Device Regulation