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, 2013-2014
• 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
Articles / Publications
see more articles
FDA Announces Intention to Regulate LDTs as Devices,
August 7, 2014
FDA and LDTs,
April 9, 2014
Thomson Reuters Book: Commercialisation of Health Care,
November 4, 2013
The Long and Winding Road to FDA Regulation of LDTs,
Draft Guidance on Medical Device Recalls: Improvements Are Needed,
July / August 2013
see more speaking engagements
Digital Pathology Association - Pathology Visions 2014, October 20-21, 2014
Association of Medical Diagnostics Manufacturers; 2014 IVD Focus Meeting, October 16, 2014
Discussion re Global Regulation of Drugs and Devices, May 15, 2014
The Nuts-and-Bolts of the Drug Quality and Security Act: An FDLI Webinar, December 4, 2013
IVD Technology's IVD Business Strategy Conference , November 6 - 8, 2013
Comprehensive Status Update on IVD Regulations - Navigating the FDA IVD Approvals Process
see more blog entries
FDA Issues Draft LDT Guidance Documents; Provides 120-Day Comment Period and will Host October Public Meeting,
October 2, 2014
FDA Notifies Congress of Draft Guidance Documents Regarding Laboratory Developed Tests,
August 4, 2014
Reflecting on the First Year of CDRH's 510(k) Refuse to Accept Policy,
February 26, 2014
CDRH Issues Final Guidance on Research Use Only and Investigational Use Only In Vitro Diagnostics Products,
December 3, 2013
The Mystery of the Missing MDR Notice,
July 21, 2013