Stephen D. Terman
Senior Counsel
- Washington, DC
- sterman@ofwlaw.com
- W: (202) 518-6369
- C: (301) 758-2000
Drawing from his background and experience while working for the FDA’s Office of Chief Counsel and as the medical device attorney for AdvaMed (formerly HIMA), Steve advises, counsels and defends medical device companies and individuals working in the medical technology profession in all areas of FDA medical device law, including FDA regulatory issues and litigation. While at OFW Law, he has represented over 300+ small & large medical device corporations, banks, investment companies, venture capitalists, and accountants, as well as assisted other law firms and professionals engaged in matters requiring expertise in FDA medical device law and regulation.
Stephen’s expertise covers all areas of medical device law including:
Medical Device applications and approvals:
- Development of strategies and assistance in bringing medical devices to market, including help in preparing IDE, 510(k), and PMA submissions.
- Classification and reclassification of medical devices.
- Medical device listing and establishment registration requirements.
- Matters concerning clinical trials.
- Pre-submission advocacy with key FDA officials.
- Assistance with highly specialized medical device regulatory matters, such as medical software, combination products, custom and breakthrough devices.
FDA Litigation & Compliance
- All types of FDA litigation, including criminal, civil penalty, injunction, and clinical disqualification cases, including providing litigation support in lawsuits involving FDA medical device issues.
- Compliance with Medical Device Reporting (MDR) requirements.
- Compliance with Quality System Regulation (QSR) requirements &employee education and quality system audits.
- Pre- and post-distribution issues regarding the labeling, advertising, and promotion of medical 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 import and export issues.
- Responding to Warning Letters.
- Due diligence work.
- Providing advice on contractual language for mergers and acquisitions involving medical device firms.
- Assisting with the formulation and preparation of FDA-related disclosures and statements for Securities and Exchange Commission (SEC) filings for medical device firms.
Teaching & Speeches
- Steve currently teaches Food and Drug Law to FDA's Center for Device and Radiological Health personnel.
- 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.
“Based on my 45 years practicing FDA Medical Device Law, and my experience working in FDA’s Office of Chief Counsel, I have an understanding of how to work with FDA to accomplish my clients’ objectives.”
– Stephen D. Terman
Credentials
Education
University of Maryland, B.S. in economics in 1973 (Phi Kappa Phi) and J.D. in 1976
Bar Admissions
Maryland, 1976
District of Columbia, 1979
Court 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
Leadership & Community
Honors
- Phi Kappa Phi
- Beta Gamma Sigma
- Omicron Delta Epsilon
Awards
- FDA Award of Merit for outstanding consumer protection efforts
- FDA 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.
- Best Lawyers in America- 2019, 2020, 2021, 2022, 2023, 2024.
- Best Lawyers in D.C.- 2014, 2015, 2016, 2019, 2022, 2023, 2024.
- Super Lawyers i - 2014, 2015, 2016, 2017, 2018, 2019, 2020.
- Lawyer of the Year - D.C.- 2016.
- Top Attorneys in D.C.- 2013, 2015.
- Washington D.C. Best Legal Minds- 2013.
- Washingtonian Magazine, Washington D.C.’s top FDA lawyers 2007, 2008, 2010, 2011, 2013, 2015, 2016, 2017, 2018.
- International Who’s Who of Life Sciences Lawyers 2008, 2010, 2012, 2013, 2014, 2015, 2016.
- Washington DC Super Lawyers 2014.
- Best Lawyers in America, FDA Law, 2013, 2014, 2015, 2016, 2017, 2022, 2023, 2024
- Martindale-Hubbell Top rated Lawyer 2014, 2015.
- Peer Review Rated as AV® Preeminent™, the highest performance rating in Martindale-Hubbell's peer review rating system, 2010, 2011, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2023.
- Martindale-Hubbell™ Top Rated Litigator 2020.
- Lawyers of Distinction - 2023.
- Elite Lawyers - 2022, 2023.
- Top Rated Lawyers - Litigator 2023.
- Top Rated Lawyers - Washington D.C.- 2023.
- Global Law Experts - 2023.
- Who's Who Legal - Life Sciences - 2023.
- Law Eagles of America- 2023.
