Hogan Lovells Publications
FDA’s software Pre-Cert program: More details revealed
09 August 2017
Partner, Washington, D.C.
Email jonathan.kahan@hoganlovells.com
Phone +1 202 637 5794
Fax +1 202 637 5910
Practice groupRegulatory
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.
Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA
Life Sciences: Regulatory/Compliance (Nationwide), Recognised Practitioner
Chambers USA
Food and Drugs
Washington, D.C. Super Lawyers
FDA Law
Best Lawyers in America
Most Highly Regarded Firms for Life Sciences
Who's Who Legal
FDA
Washington, D.C. Super Lawyers
Washington's Top Lawyers: Food and Drug
Washingtonian
Handbook, Recommended Specialist in 'Life Sciences: Regulatory'
PLC Which Lawyer?
Regulatory Star
LMG Life Sciences
Regulatory: Medical Devices
PLC Life Sciences Cross-border Handbook
Leading Lawyer in Regulatory: Medical Devices
PLC Life Sciences Cross-border Handbook
Medical Device & Diagnostic Industry, Hundred Notables of the Medical Device Industry
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
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.
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