Jeffrey N. Gibbs Director 202-737-4288
Jeffrey N. Gibbs


Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medical device and IVD companies.

Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient, practical, timely and insightful guidance. He has worked with companies of all sizes, from global manufacturers to one-person start-ups.

Mr. Gibbs has written and lectured extensively on a variety of FDA topics, particularly the regulation of medical devices, IVDs, and enforcement matters. He was a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, serving as chair from 2003 to 2004. He was also a member of George Mason University’s Human Subjects Research Board from 2003 to 2011. He was a member of the Board of Directors of the Food and Drug Law Institute from 2009 to 2019, serving as both General Counsel and Chairman.  He has received numerous recognition awards, including, “Life Sciences: Regulatory/Compliance – USA” Chambers and Partners Global (2021); Washington D.C. Super Lawyers (2021); “Who’s Who Legal: Life Sciences 2021”; “The Best Lawyers in America” (27th Edition-2021); “Who’s Who Legal: Life Sciences 2020”; Washington D.C. Super Lawyers (2020); LMG Life Science’s Star (2019); “The Best Lawyers in America” (26th Edition-2020); “Who’s Who Legal: Life Sciences 2019”; “The Best Lawyers in America” (25th Edition-2019); LMG Life Sciences Hall of Fame Award (2018); “Who’s Who Legal: Life Sciences 2018”; Chambers & Partners (2018); Washington D.C. Super Lawyers (2018); “The Best Lawyers in America” (24th Edition-2018); “Who’s Who Legal: Life Sciences 2017”; LMG Life Science’s Star (5th Edition-2016); “The Best Lawyers in America” (23rd Edition-2017); “Top FDA Lawyers,” Best Lawyers Supplement, The Washington Post (2016); Washington D.C. Super Lawyers (2016); “The Best Lawyers in America” (22st Edition-2016); Washington D.C. Super Lawyers (2015); LMG Life Science’s Star (4th Edition-2015); “Top FDA Lawyers,” Best Lawyers Supplement, The Washington Post (2015); “Who’s Who Legal: Life Sciences (2015); and “The Best Lawyers in America” (21st Edition-2015). Mr. Gibbs was co-editor and co-author of “European Lawyer Reference: Commercialisation of Health Care, Jurisdictional,” published by Thomson Reuters in 2013, 2015, and 2018, and “Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment,” published by the Food and Drug Law Institute in 2021.

Mr. Gibbs was Associate General Counsel for Enforcement at FDA, where he received an Award of Merit. He also was appointed Special Assistant U.S. Attorney for the District of Columbia, and, earlier in his career, clerked for a U.S. District Court Judge in New Jersey.

Education & Admissions


J.D., with honors, New York University School of Law
A.B., summa cum laude, psychology, Princeton University


District of Columbia


Medical Devices

  • Helps clients develop regulatory strategies, including investigational device exemptions, 510(k) clearance, and PMA approvals.
  • Advises companies on compliance with post-market regulations, including adverse event reporting, labeling and advertising, Part 806 reporting, QSR, and product modifications.
  • Provides guidance on IDEs, clinical studies, and informed consent.
  • Counsels clients on enforcement actions, including Form 483s, warning letters, product recalls, and injunctions.
  • Advises companies on FDA regulation of software and mobile apps.
  • Counsels medical device companies on compliance with labeling, advertising, and promotion regulations.

In Vitro Diagnostic Devices

  • Helps clients develop regulatory strategies for clearance and approval, as well as marketing claims. =
  • Assists with the pre-submission process.
  • Provides guidance on Laboratory Developed Tests (LDTs).
  • Provides advice on requirements for RUO assays and instruments.
  • Assists with post-market compliance.

Product Jurisdiction

  • Advises companies on product jurisdiction strategies.

Honors & Awards

  • Chambers and Partners,
    Global: Life Sciences, Band 1, 2020
  • FDA Medical Device Attorney of the Year LMG Life Sciences 2014
  • Best Lawyers FDA Law 2014, 2019, 2021-2024
  • Chambers and Partners Nationwide: Life Sciences, Band 3 2014
  • Chambers and Partners Washington, D.C. Healthcare, Band 2 2014
  • Top FDA Lawyer Best Lawyers Supplement 2014
  • DC Super Lawyer Food & Drug 2013-2016
  • Washingtonian Top Lawyer Food and Drug 2014
  • Life Science Star LMG Life Sciences 2014, 2023 (Hall of Fame)
  • FDLI Distinguished Service and Leadership Award 2013
  • Chambers and Partners “Leaders in their Fields,” Healthcare: Pharmaceutical/Medical Products Regulatory 2013
  • Chambers and Partners Washington, D.C., Band 3 2012
  • The International Who’s Who of Business Lawyers Life Sciences 2014 – 2016
  • Who’s Who Legal
    (Life Science) 2021
  • Who’s Who Legal: Thought Leaders – Global Elite

Speaking Engagements

  • Webinar, Presenter, “LDT Final Rule:  Beyond the Five Stages – Tactical and Strategic Considerations”, June 18, 2024
  • Webinar, Presenter, “Regulatory Changes Unpacked: Expert Insights into the FDA’s Oversight of LDTs in Digital Pathology”, May 23, 2024
  • Co-Presenter, FDANEWS Webinar; “The Biden Administration’s FDA:  A Remarkable 2021, What to Expect in 2022”, January 20, 2022
  • FDLI, Enforcement, Litigation, and Compliance Conference for the Drug, Device, Food and Tobacco Industries, Moderator: Diagnostics: FDA Policies, Enforcement Priorities, and Patent Legislation, December 10, 2021
  • AMDM Virtual Focus Meeting, VALID Act, What’s Next?, October 1, 2021
  • FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, Topical Facilitated Discussions: Diagnostics Reform, May 18-20, 2021
  • FDLI, Food and Drug Law Journal 2020 Symposium:  This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness, November 12-13, 2020
  • Moderator, FDLI Webinar, FDA’s Legal Authority Over Laboratory Developed Tests, November 10, 2020
  • AMDM Virtual IVD Focus Meeting, EUA for COVID-19, October 16, 2020
  • Precision Medicine World Conference, Panelist: PGx Policy Making in Real Time, January 21-24, 2020
  • FDLI’s Introduction to Drug and Device Law and Regulation for Patent Organizations, Approval and Clearance Pathways for Medical Devices, November 5, 2019
  • AMDM IVD Focus Meeting,  Common Regulatory Errors by IVD Companies and how to avoid them, October 3-4, 2019
  • Q1 Combination Products Regulation Conference, Optimizing Primary Mode of Action Determination & Process to Appeal FDA Decisions, February 28, 2019
  • Eleventh Annual IVD Regulatory Affairs Conference, Regulatory Overview:  The Future of Laboratory Developed Tests, December 5-6, 2018
  • FDA: Past, Present and Future Conference, FDA’s Role in Governance of Black-Box Medicine, October 19, 2018
  • Food and Drug Law Institute Annual Conference:  Exploring Advanced Topics in Food and Drug Law, Digital Health Developments and Changing Regulatory Approaches, May 3-4, 2018
  • Fieldfisher – Selling Medical Devices:  Embracing the Challenges and Opportunities of Regulatory Change, Digital devices:  Wellness apps vs. medical devices, March 1, 2018
  • FDA Boot Camp Device Edition, Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways, July 27-28, 2017
  • FDLI Annual Conference, Patient-Centric Perspectives: Models for Patient Engagement, May 4-5, 2017
  • 2017 AMDM Annual Meeting, Benefit-Risk Analyses and IVDs, April 26-27, 2017
  • TEDCO/Sinai Hospital BioIncubator Distinguished Speaker Series Seminar, FDA and Regulatory Affairs, February 23, 2017
  • AMDM 2016 IVD Focus Meeting, The Case of the Unluckiest IVD Company: Compliance Case Study, Part 1 and 2, October 14, 2016
  • National Asian Pacific America Bar Association Southeast Regional Conference, September 30, 2016
  • Health Policy Conference, FDA Outlook for Clinical Labs, September 15, 2016
  • American Conference Institute Boot Camp Devices Edition, July 20, 2016
  • 2016 Food and Drug Law Institute Annual Conference, Breakout Session, May 5, 2016
  • Hot Topics in Medical Device Law, The Regulation of Laboratory-Developed Tests, March 31, 2016

Articles & Publications


J.D., with honors, New York University School of Law
A.B., summa cum laude, psychology, Princeton University


District of Columbia

Practice Areas
FDA Regulatory Categories