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

Overview

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

Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient 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 currently serves as chairman for the Food and Drug Law Institute, and serves on the LifeBridge Innovation Council, Sinai Hospital, Baltimore, MD. He has received numerous recognition awards, including, “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 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

Education

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

Admissions

District of Columbia

Experience

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

  • FDA Medical Device Attorney of the Year LMG Life Sciences 2014
  • Best Lawyers in America FDA Law 2014
  • 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
  • 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

Speaking Engagements

  • FDA Boot Camp, Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations, March 25-27, 2019
  • Trans Comet Course, US Regulation of Devices, Their Impact on Commercialization, and Tools for Expediting Entry into the US Market, April 24-26, 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
Education

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

Admissions

District of Columbia

Practice Areas
Industries
FDA Regulatory Categories