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
Thomas Reuters Commercialisation of Healthcare,
October 1, 2015
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
see more speaking engagements
Hot Topics in Medical Device Law, March 31, 2016
The Regulation of Laboratory-Developed Tests
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
see more blog entries
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
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