Press Releases
Hogan Lovells secures FDA emergency use authorization for Lucira Health for breakthrough OTC COVID-19 and flu test
07 March 2023
PartnerWashington, 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.
Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia), Senior Statespeople
Chambers USA
Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA
Healthcare: Life Sciences, Recommended
Legal 500 US
Distinguished Service and Leadership Award
Food and Drug Law Institute
Life Sciences: Regulatory/Compliance (Nationwide), Recognised Practitioner
Chambers USA
Hall of Fame
LMG Life Sciences
Food and Drugs
Super Lawyers
FDA Law
Best Lawyers in America
Most Highly Regarded Firms for Life Sciences
Who's Who Legal
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., 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
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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