Stephen D. Terman | OFW Law | Washington, D.C.
Steve Terman is a principal at OFW Law and concentrates his practice in the areas of medical device law, FDA regulatory issues, and litigation. While at OFW Law, he has represented over 250 corporations, individuals and associations in civil, criminal, and regulatory matters. Steve’s expertise covers all areas of medical device law including: litigation matters; development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of necessary regulatory filings; compliance with Medical Device Reporting (MDR) requirements, including employee education and system audits; classification and reclassification of medical devices; compliance with Quality System Regulation (QSR) requirements, including employee education and system audits; pre- and post-distribution issues regarding the labeling, advertising, and promotion of medical devices; highly specialized medical device regulatory matters, such as medical software, combination products and custom devices; managing risks associated with and responding to FDA enforcement actions; preparing for and managing FDA inspections; conducting product recalls and other field actions; medical device listing and establishment registration requirements; medical device import and export issues and matters concerning clinical trials.
In 1990, Steve joined OFW Law and has concentrated his practice in medical device law and FDA regulatory issues. He has helped companies respond to Warning Letters and recalls, and has successfully defended individuals and companies in criminal, civil penalty, injunction, and clinical disqualification cases. He has done extensive due diligence work for a variety of clients including FDA-regulated companies, banks and investment companies, as well as assisted other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in FDA medical device law and regulation. Steve has also been retained to provide advice on contractual language for mergers and acquisitions involving medical device firms. In addition, he has provided litigation support in lawsuits involving FDA medical device issues as well as assisting with the formulation and preparation of FDA-related disclosures and statements for Securities and Exchange Commission (SEC) filings for medical device firms.
In addition to writing and editing book chapters and articles, Steve has given hundreds of speeches and is a frequent lecturer before trade and professional groups including AAMI, AdvaMed, AFDO, ACI, FDLI, HMS, IBC, MedTech, and RAPS. He currently teaches Food and Drug Law to FDA’s Center for Device and Radiological Health personnel.
Prior to joining OFW Law, Steve worked in the Office of Chief Counsel, U.S. Food and Drug Administration from 1976-1987 where he served as Associate Chief Counsel for Enforcement. While at FDA, 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.
In 1987, Steve joined the Health Industry Manufacturer’s Association (HIMA) now AdvaMed, a national trade association representing over 300 medical device, diagnostic product and healthcare information systems manufacturers. While at HIMA, he served as Associate General Counsel where he was responsible for handling the Association’s FDA-related legal, regulatory, and Congressional issues.
Steve 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. He 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.
Medical Device Regulation and Compliance, Food Drug and Law Institute, 2010.
“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.