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, 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.
• 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.
• Advises companies on product jurisdiction strategies.
Awards & Recognition
• 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
Articles / Publications
see more articles
• LDTs: The Saga Continues,
• A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory Violation,
September 7, 2016
• FDA Seeks Methods to Better Regulate NGS Products,
• FDA and Product Jurisdiction: Time for Reforms,
February 1, 2016
• Thomas Reuters Commercialisation of Healthcare,
October 1, 2015
see more speaking engagements
• 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, May4-5, 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
• 2016 IVD Focus Meeting, The Case of the Unluckiest IVD Company / Compliance Case Study Parts 1 and 2, October 13-14, 2016
see fewer blog entries
• No Final LDT Guidance, But FDA Provides Insight into What a Future Guidance Might Contain,
January 26, 2017
• FDA Will Not Finalize Draft LDT Guidances in 2016 – But That’s Not the End of LDT Regulation,
November 21, 2016
• A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification May Be More Than a Regulatory Violation,
August 15, 2016
• Two New Draft Guidances Outline FDA’s Proposed Approach to Regulatory Oversight of Next Generation Sequencing Diagnostic Tests,
July 24, 2016
• Long-Awaited Draft Guidances on Next Generation Sequencing Diagnostic Tests Released Today,
July 7, 2016
• Happy 40th Birthday Medical Device Amendments – You’re Officially Over-the-Hill,
• 510(k) Clearance “Corrected” 19 Years after Original Clearance,
April 1, 2016
• Premarket Sterility Guidance for Devices is the Latest in a Flurry (Blizzard Pun Intended) of Device Guidance Activity for FDA,
January 31, 2016
• FDA Plans to Issue Final LDT Framework in 2016; Subcommittee Members, CMS and FDA Officials Critique Proposed Legislative Approach that Would Give CMS,
December 20, 2015
• Back from Break: FDA Issues Letter to Pathway Genomics for Cancer Screening LDT; Proposed Legislative Alternatives to FDA Framework Continue to Emerge,
September 29, 2015