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. Mr. Gibbs was a member of George Mason University's Human Subjects Research Board from 2003 to 2011. Mr. Gibbs currently serves as secretary and general counsel for the Food and Drug Law Institute, and is a guest lecturer for the University of Maryland's Regulatory Law: Medical Devices course.
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
Outcome of LDT Regulation Controversy Defies Forecasting,
July 21, 2015
510(k) Statistical Patterns,
December 2, 2014
GEN LDT Article-New LDT Guidance Documents Face Scrutiny,
November 7, 2014
FDA Announces Intention to Regulate LDTs as Devices,
August 7, 2014
FDA and LDTs,
April 9, 2014
see more speaking engagements
IVD Regulatory adn Strategic Forum, December 8-9, 2015
Wolrd cafe: Taking a closer look at IVD markets globally
The Regulatory Convergence, October 24-28, 2015
“Advertising and Promotion of IVDs”
2015 Advertising and Promotion Conference, October 1-2, 2015
Mobile Medical Applications: FDA & FTC Issues
Because the definition of a medical device depends on its intended use, which is established through labeling, advertising, and statements by the manufacturer, it is critical that companies exercise care when promoting products. Even if a device is low risk, the FTC retains the authority to take enforcement action for false or misleading claims. In this session, panelists will discuss the special considerations posed by the availability and promotion of mobile medical applications.
AMDM Annual Conference, April 22-23, 2015
April 22nd at 2:45pm, Jeff Gibb's will be speaking
2015 Annual Membership Meeting - Hearing Industries Association, March 4, 2015
see more blog entries
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
Combination Products Reform Bill Is A Good Start, But Its Provisions Need Strengthening,
August 6, 2015
Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework,
April 16, 2015
New Article Shows Surprising Trends in 510(k) Review Times,
December 14, 2014
As Part of Effort to Prepare 21st Century Cures Legislative Discussion Draft, House Committee Seeks Comment on FDA Proposed Framework to Regulate LDTs,
December 11, 2014