jjsmith@hhlaw.com
PHONE
+1.202.637.3638
FAX
+1.202.637.5910
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John
J.
Smith, M.D., J.D.
Partner,
Washington, D.C.
John Smith's practice focuses primarily on assisting medical device companies in successfully addressing U.S. Food and Drug Administration (FDA) regulatory issues. A former associate professor at Massachusetts General Hospital/Harvard Medical School, John has extensive regulatory experience both in representing his clients at Hogan & Hartson and as the founding Director of the Regulatory Affairs Program at the Center for Integration of Medicine and Innovative Technology (CIMIT), a nonprofit consortium of the Harvard Medical Institutions and the Massachusetts Institute of Technology dedicated to medical product development. He has also served as a consultant to the Radiological Devices Panel of the Medical Devices Advisory Committee at FDA’s Center for Devices and Radiological Health. In addition to his legal background, John has broad medical practice experience as a board certified, fellowship-trained musculoskeletal radiologist in both the academic and private practice settings, providing clinical care and taking part in clinical trials.
John has written numerous articles on the regulatory issues surrounding new medical technology in both the medical and legal literature, and has been an invited speaker in a variety of industry, medical, academic, and government settings.
John is active with a number of professional and nonprofit organizations, including the Radiological Society of North America, where he chairs the Committee on Resolutions and Bylaws and the American College of Radiology, where he is the former chair of the Safety Committee.
REPRESENTATIVE EXPERIENCE
Assisting a company in drafting an Investigational Device Exemption (IDE) for an implantable motion preserving spinal device.
Assisting in the preparation of premarket submissions for both diagnostic and therapeutic radiology products for a variety of companies and organizations, ranging from startups to major corporations.
Assisting a company in successfully obtaining an Investigational Device Exemption (IDE) approval for a novel, “first in class” dental therapy device following an initial IDE disapproval letter.
Reviewing the medical and scientific accuracy of claims made by a company’s competitor in promotional materials and formulating possible regulatory options.
Assisting a company in drafting the clinical section of its PMA for a “first in class” implantable orthopedic device.
Representing multiple clients in successful supervisor appeals at the Center for Device’s and Radiological Health.
Published Works
January 2008
"FDA Regulation of Implantable Sensors: Demonstrating Safety and Effectiveness for Marketing in the U.S." IEEE Sensors Journal, Vol. 8, No. 1
PUBLISHED WORKS PRIOR TO JOINING HOGAN & HARTSON
Smith JJ, Henderson JA. The Food and Drug Administration and Molecular Imaging Agents: Overview and Analysis of Current Regulatory Challenges. Journal of the American College of Radiology (2005).
Smith JJ, Henderson JA. Medical Devices and the Food and Drug Administration: Regulating the Tools of Radiology. Journal of the American College of Radiology (2005).
Smith JJ, Seigeur E. Perception and Process at the Food and Drug Administration: Obligations and Trade-offs in Rules and Guidances. Food and Drug Law Journal (2005).
Kaplan AV, Baim DS, Smith JJ, et al. Medical Device Development: From Prototype to Regulatory Approval. Circulation 109:3068-3072 (2004).
Smith JJ, Brenner RJ. The Malpractice Liability Crisis: Moving Towards Workable Solutions. Journal of the American College of Radiology 1:249-254 (2004).
Smith JJ, Berlin L. Malpractice Issues in Radiology: Medicare Fraud and Abuse. American Journal of Roentgenology 180:591-595 (2003).
Smith JJ, Sorensen AG, Thrall JH. Biomarkers In Imaging: Realizing Radiology’s Future. Radiology 227:633-638 (2003).
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