Stephen D. Terman | Attorney

Mr. Terman is a principal at Olsson Frank Weeda Terman Bode Matz P.C. He was born in Washington, D.C., and received his B.S. in economics in 1973 from the University of Maryland where he was Phi Kappa Phi and his J.D. in 1976, also from the University of Maryland. Mr. Terman was admitted to the Maryland Bar in 1976 and the District of Columbia Bar in 1979. He is currently a member of the District of Columbia Bar.

Mr. Terman concentrates his practice in medical device law, FDA regulatory issues, and litigation. While at Olsson Frank Weeda Terman Bode Matz PC, he has represented over 200 corporations, individuals and associations in civil, criminal and regulatory matters. Mr. Terman's expertise covers all areas of medical device law including the Quality System Regulation, Medical Device Reporting, IDE, 510(k) and PMA submissions. He has helped companies respond to FDA inspectional observations, Warning Letters and recalls, as well as civil penalty actions, injunctions, clinical disqualifications and criminal prosecutions. Until joining the firm in 1990, he served as Associate General Counsel of the former Health Industry Manufacturers Association (HIMA) now AdvaMed, a national trade association representing over 300 medical device, diagnostic product and healthcare information systems manufacturers. While at HIMA, he was responsible for handling the Association's FDA-related legal, regulatory, and Congressional issues. Before joining HIMA in 1987, Mr. Terman served as Associate Chief Counsel for Enforcement, U.S. Food and Drug Administration, where he received the prestigious Award of Merit for outstanding consumer protection efforts, and the Commendable Service Award in recognition of superior performance in litigating complex enforcement cases raising significant questions concerning the agency's jurisdiction and the scope of its authority. Mr. Terman worked for the U.S. Food and Drug Administration from 1976-1987. Mr. Terman has given hundreds of speeches and is a frequent lecturer before trade and professional groups including AdvaMed, RAPS, FDLI, IBC, AAMI, HMS and AFDO. In 1995, Mr. Terman successfully defended a former USCI Bard employee charged with conspiracy to defraud the FDA in U.S. George Maloney, et. al., in Boston Massachusetts. In 2007, Mr. Terman was honored by the Washingtonian Magazine as one of Washington, D.C.'s top FDA lawyers.  Mr. Terman was also nominated by his peers as one of the world's leading practitioners in his field, and is listed in the International Who's Who of Life Sciences Lawyers 2008.

Areas of Practice:

Medical Device Law
Food and Drug Law
Litigation

Bar Admissions:

Court of Appeals of Maryland, 1976
United States Fourth Circuit Court of Appeals, 1977
United States District Court for the District of Maryland, 1977
United States Eighth Circuit Court of Appeals, 1978
United States Ninth Circuit Court of Appeals, 1978
United States Court of Appeals for the District of Columbia, 1979
United States District Court for the District of Columbia, 1979
District of Columbia Court of Appeals, 1979
Supreme Court of the United States, 1980
United States Seventh Circuit Court of Appeals, 1981

Education:

University of Maryland School of Law, Baltimore, Maryland, 1976
Juris Doctor
University of Maryland, College Park, Maryland, 1973
Bachelor of Science, High Honors
Honors: Phi Kappa Phi, Beta Gamma Sigma, Omicron Delta Epsilon

Published Works:

Food and Drug Administration Regulation of Blood Bank Software: The New Regulatory Landscape for Blood Establishments and Their Vendors, 38 Transfusion 86, 1998

Bard Case Set Bad Precedents, 14 Food Drug Cosm. & Medical Devices Law Digest No. 1:1-8, NY State Bar Association, 1997

The Medical Device Amendments of 1976 and 1990 A Statutory Overview, Sterilization Technology, Van Nostrand Reinhold New York, 1993

Chapters on Biomedical Instrumentation and Technology on the Safe Medical Devices Act of 1989 and Complying With the Medical Device Reporting Regulation, The Medical Device Industry, Science, Technology and Regulation in a Competitive Environment, 1990.