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 fewer 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
• National Asian Pacific American Bar Association Southeast Regional Conference, TBD, September 30, 2016
• Health Policy Conference, FDA Outlook for Clinical Labs, September 15, 2016
• ACI’s FDA Boot Camp Device Conference, 7/21 Co-Speaker: “Pathways to Approval", July 20-22, 2016
• FDLI Annual Conference, Jeff Gibbs will be speaking on May 5 for the breakout session at the 2016 FDLI Annual Conference., May 5-6, 2016
• Hot Topics in Medical Device Law, The Regulation of Laboratory-Developed Tests, March 31, 2016
• IVD Regulatory adn Strategic Forum, Wolrd cafe: Taking a closer look at IVD markets globally, December 8-9, 2015
• The Regulatory Convergence, “Advertising and Promotion of IVDs”, October 24-28, 2015
• 2015 Advertising and Promotion Conference, 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., October 1-2, 2015
• AMDM Annual Conference, April 22nd at 2:45pm, Jeff Gibb's will be speaking, April 22-23, 2015
• 2015 Annual Membership Meeting - Hearing Industries Association, FDA Update, March 4, 2015
• American Society for Pharmacy Law - Developments in Pharmacy Law, Maintaining an Effective Controlled Substance Compliance Program, November 6-9, 2014
• Digital Pathology Association - Pathology Visions 2014, Regulatory Update, October 20-21, 2014
• Association of Medical Diagnostics Manufacturers; 2014 IVD Focus Meeting, Legislative Update, October 16, 2014
• Discussion re Global Regulation of Drugs and Devices, Panel member, May 15, 2014
• The Nuts-and-Bolts of the Drug Quality and Security Act: An FDLI Webinar, Moderator, December 4, 2013
• IVD Technology's IVD Business Strategy Conference, Comprehensive Status Update on IVD Regulations - Navigating the FDA IVD Approvals Process, November 6 - 8, 2013
• LMG Life Sciences, FDA Medical Device Attorney of the Year, September 2013
• DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences, Frame your Upcoming Diagnostics Development within a Firm Understanding of FDA Expectations, June 23 - 27, 2013
• AMDM's 40th Annual Meeting & OIVD Submissions Workshop, Ten Tips for IVD Manufacturers, April 17 - 20, 2013
• New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section, Medical Device Legal Update, January 24, 2013
• DIA 7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Healthcare, Tutorial Instructor for "Personalized Medicine" session
Panelist for "Regulatory, Ethical and Social Policy Issues in Personalized Medicine: Discovery to Clinic" session
Panelist for "Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communications with the FDA" session, November 1 - 4, 2012
• Clinical Affairs and Regulatory Approvals for Diagnostics Conference, Panelist for the Round Table Discussion: "Best Practices in Working with FDA Reviewers to Secure Regulatory Approval", September 10 - 11, 2012
• Drug Information Association (DIA) Annual Conference, Legal Jeopardy from the Conduct of Clinical Trials session panelist., June 24 - 28, 2012
• FDLI Medical Device Regulation and Litigation Conference, Panel member for session on "Hot Topics in Medical Device Regulation: 510(k) Process; Risk Management; Social Media", June 18, 2012
• Association of Medical Diagnostics Manufacturers Annual Meeting, Advertising and Promoting In Vitro Diagnostics, April 19 - 20, 2012
• AdvaMed: Avoiding A Warning Letter, Hands on Interactive Session: How to Respond to 483s and Warning Letter, December 9, 2011
• R&D Portfolio Management for Medical Devices, Understanding the Potential Impact of Changes to the FDA 510(k) System, December 1 - 2, 2011
• Biomarker Applications For Improved Clinical Trial Outcomes, Prepare your Clinical Trials for Compliance with New FDA Regulations on LDTs and IVDs, November 15 - 16, 2011
• ACI FDA Boot Camp Device Edition, The Basics: Understanding and Working with the FDA - Jurisdiction, Functions, Organization, and Operations, October 25 - 26, 2011
• DIA Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams, CDRH Breakout Session Moderator, February 23, 2011
• American University Washington College of Law Founders' Event, Personalized Medicine: Ethics, Privacy, DNA and the Future of Medicine (Panelist), February 15, 2011
• Personalized Medicine World Conference, Panel participant on "Aligning The Regulators and Industry To Accelerate Personalized Medicine Benefits", January 19, 2011
• Annual Fall AIPLA Meeting, AIPLA Joint Biotechnology Committee/Special Committee - Gene Patents & Diagnostic Tests, October 21 - 23, 2010
• European Pharmaceutical Regulatory Law Conference, September 22 - 23, 2010
• Cambridge Healthtech Institute's Accelerating Development & Advanceing Personalized Therapy Conference, FDA Regulation of Protein-Based Diagnostic Tests, September 13 - 16, 2010
• FDLI Webinar: FDA's (Emerging) Oversight of Laboratory - Developed Tests, Moderator, August 4, 2010
• DIA 46th Annual Meeting, June 13, 2010
• Diagnostic Marketing Association's Annual Conference, New Product Approval Requirements at the FDA, April 7, 2010
• ACI's FDA Boot Camp, Regulation and Dessemination of Off-Label Information, March 24 - 25, 2010
• FDLI Introduction to Medical Device Law and Regulation Conference, November 17, 2009
• Clinical Proteomic Technologies for Cancer (CPTC) 2009 Annual Meeting, October 7, 2009
• Genetic Alliance Webinar, Genetic Testing In A Changing Regulatory Landscape, September 16, 2009
• FDLI Audioconference Moderator, IRB Closures: Avoiding and Managing the Unexpected in Clinical Trials, June 19, 2009
• Chair of "Meet the CDRH Director" session at the 2009 FDLI Annual Conference., April 22 - 23, 2009
• ALHA Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions Conference, January 29 - 30, 2009
• Cambridge Healthtech Institute 8th Annual PEP Talk, "Implementing the Next-Generation of Antibodies: Capturing the Competitive Edge" and "Protein Diagnostic Development" meetings, January 15 - 16, 2009
• Goldman Sachs Inaugural Diagnostics Conference, On the Regulatory / Reimbursement Trends panel, September 18, 2008
• Food and Drug Law Institute Conference, Personalized Medicine - Promises & Challenges, June 20, 2008
• IACP's Annual Meeting & Compounders on Capitol Hill, June 2, 2008
• Licensing Executives Society Annual Conference, May 7, 2008
• Pharma MedDevice Conference, A Look At IVD Regulation, March 26 - 28, 2008
see more 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