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Jonathan S. Kahan

Partner
Washington, D.C.

Jonathan S. Kahan

With more than 40 years of legal experience, Jonathan Kahan is an industry leader in obtaining FDA market clearance of novel medical devices for medical technology and diagnostics companies. He also advises on post-market compliance matters.

Jonathan helps clients navigate complicated regulatory processes, including those related to combination products such as combinations of devices, drugs, biologics, and human tissues. He authored the leading text on medical device law, Medical Device Development: Regulation and Law; (Parexel 2014).

Jonathan is co-director of the firm's Medical Device Practice Group and an adjunct professor who teaches medical device law at the George Washington University Law School. He is also the general counsel of the Association of Medical Diagnostics Manufacturers.

Jonathan is highly ranked by Chambers as well as all other rating services, and has been consistently included in Washington, D.C. Super Lawyers and Washingtonian Magazine's Top Lawyers in D.C.

Areas of Focus

Representative Experience

Assisted client in obtaining premarket approval (PMA) for a novel medical device to treat brain cancer.

Assisted client in obtaining a Humanitarian Device Exemption approval for a novel device that brings sight to patients blinded by retinitis pigmentosa.

Represented a medical device client in resolving a civil money penalty proceeding brought by the FDA.

Assisted client in obtaining de novo reclassification for a novel pill camera for imaging lesions in the colon.

Assisted client in obtaining 510(k) clearance for multiple proton beam therapy systems.

Assisted client in obtaining PMA for a novel gastric balloon system for the treatment of obesity.

Assisted client in the filing of a Request for Designation with the FDA OCP and obtaining a favorable device jurisdictional ruling.

Advised client regarding whether clinical decision software was regulated by the FDA as a medical device.

Education and admissions

Education

  • J.D., with honors, Order of the Coif, The George Washington University Law School, 1973
  • B.A., with honors, The George Washington University, 1970

Memberships

  • Contributing Editor, Medical Device & Diagnostic Industry Magazine (MD&DI)
  • General Counsel, Association of Medical Diagnostics Manufacturers
  • Member, American Bar Association
  • Member, Editorial Advisory Board, MD&DI 

Bar admissions and qualifications

  • District of Columbia

Court admissions

  • U.S. Court of Appeals, District of Columbia Circuit
  • U.S. District Court, District of Columbia
  • U.S. Supreme Court

2006-2011, 2015-2016

Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers USA

2015

FDA Law

Best Lawyers in America

2014-2015

Food and Drugs

Washington, D.C. Super Lawyers

2013-2015

Most Highly Regarded Firms for Life Sciences

Who's Who Legal

2009-2014

Washington's Top Lawyers: Food and Drug

Washingtonian

2009-2011, 2013

FDA

Washington, D.C. Super Lawyers

2013

Regulatory Star

LMG Life Sciences

2011-2012

Regulatory: Medical Devices

PLC Life Sciences Cross-border Handbook

2011

Handbook, Recommended Specialist in 'Life Sciences: Regulatory'

PLC Which Lawyer?

2009

Leading Lawyer in Regulatory: Medical Devices

PLC Life Sciences Cross-border Handbook

2004

Medical Device & Diagnostic Industry, Hundred Notables of the Medical Device Industry

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