Jonathan S. Kahan

Jonathan S. Kahan

Partner
Washington, D.C.

Email [email protected]​hoganlovells.com

Phone +1 202 637 5794

Fax +1 202 637 5910

Practice groupGlobal Regulatory

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 2020).

Jonathan is the former director of the firm's Medical Device and Technology practice group and an adjunct professor at the George Washington University Law School teaching medical device law. He presently serves as a member of the George Washington University President's Leadership Advisory Council and he is also the general counsel of the Association of Medical Diagnostics Manufacturers.

Jonathan is highly ranked by Chambers as well as other legal directories. He has been consistently included in Washington, D.C. Super Lawyers and Washingtonian magazine's Top Lawyers in D.C. He also received the Food and Drug Law Institute (FDLI) Distinguished Service and Leadership Award, recognizing his contribution in promoting public health, advancing the medical device and technology law field, and ensuring a robust and innovative regulatory environment.

Awards and recognitions

2019-2022

Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia), Senior Statespeople
Chambers USA

2006-2020

Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA

2020

Healthcare: Life Sciences, Recommended
Legal 500 US

2020

Distinguished Service and Leadership Award
Food and Drug Law Institute

2017-2019

Life Sciences: Regulatory/Compliance (Nationwide), Recognised Practitioner
Chambers USA

2019

Hall of Fame
LMG Life Sciences

2009-2018

Food and Drugs
Super Lawyers

2015

FDA Law
Best Lawyers in America

2013-2015

Most Highly Regarded Firms for Life Sciences
Who's Who Legal

2009-2014

Washington's Top Lawyers: Food and Drug
Washingtonian

2011

Handbook, Recommended Specialist in 'Life Sciences: Regulatory'
PLC Which Lawyer?

2013, 2016-2018

Regulatory Star
LMG Life Sciences

2011-2012

Regulatory: Medical Devices
PLC Life Sciences Cross-border Handbook

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

Education and admissions

Education

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

B.A., The George Washington University, with honors, Phi Beta Kappa, 1970

Memberships

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. Supreme Court

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

U.S. District Court, District of Columbia

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 clients 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 numerous clients in the filing of a Requests for Designation with the FDA OCP and obtaining a favorable device jurisdictional rulings.

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

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