Hyman Phelps and McNamara
Jeffrey N. Gibbs
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Practice Areas
Medical Devices

J.D., with honors, New York University School of Law
A.B., summa cum laude, psychology, Princeton University

Bar Admissions
District of Columbia

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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.

Related Experience
Medical Devices
• 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.

Product Jurisdiction
• 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 fewer articles
•  LDTs: The Saga Continues,  April 2017

•  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,  September, 2016

•  FDA and Product Jurisdiction: Time for Reforms,  February 1, 2016

•  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

•  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,  October 2013

•  Draft Guidance on Medical Device Recalls: Improvements Are Needed,  July / August 2013

•  How, and When, Will FDA Regulate LDTs?,  July 15, 2013

•  FDASIA's Impact on Novel IVDs,  October 1, 2012

•  Ten Short Tips For The Medical Device Industry,  September / October 2012

•  A Year in Review: CDRH Draft Guidance Documents of 2011,  May / June 2012

•  Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center,  January 2012

•  Court Ruling Casts Doubt On FDA's Use Of Guidance Documents,  December 16, 2011

•  Draft Guidance for RUO Products Issued,  August 1, 2011

•  Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New Technology,  May 2011

•  Personalized Medicine: Improving the Regulatory Pathway,  May 2011

•  Uncertainty Persists with RUO Products - FDA May Be Considering More Restrictive Approach with Research Use Only Assays,  April 1, 2011

•  Regulating Laboratory-Developed Tests,  September 15, 2010

•  15th Anniversary Essay: Regulation Then and Now,  August 2010

•  The Problem of Regulatory Uncertainty,  July 2010

•  Regulatory Pathways for Clearance or Approval of IVDs,  May 2010

•  Oversight of Research Use Only Products,  March 1, 2010

•  In Vitro Diagnostic Tests for Cancer: Regulation of Laboratory Developed Tests,  January 2010

•  The Custom Device Exemption: What Is It And Does It Ever Apply?,  September 2009

•  Banked-Specimen Retrospective Studies,  June 15, 2009

•  Making the Most of Pre-IDE Meetings,  March 1, 2009

•  Taking control of the IVD submission process,  January 2009

•  Adroit Crafting of "Intended Use" Critical - Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words,  November 15, 2008

•  Personalized Medicine - Panacea or Pipedream?,  September 2008

•  Lessons Learned from the AbTox Ruling,  September 2008

•  Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires,  August 1, 2008

•  Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now,  July 1, 2008

•  FDA's Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities,  June 13, 2008

•  FDA's latest ASR guidance document creates more confusion and raises legal issues,  April 2008

•  Court case determines specimen ownership,  January 2008

•  Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake,  December 18, 2007

•  FDA Releases Final Guidance on ASRs,  September 14, 2007

•  FDA Issues Second Draft Version of IVDMIA Guidance,  July 25, 2007

•  Jeff Gibbs Cited as FDA Law Authority by Federal Appeals Court,  May 2007

•  Questions over FDA's Authority to Regulate Laboratory Developed Tests,  March 2007

•  ASRs and IVDMIAs: FDA's New Draft Guidances,  March 2007

•  Abigail Alliance v. von Eschenbach,  March 2, 2007

•  State of the Union: Drug-Device Combinations,  November 2006

•  Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study,  May 2006

•  Health and Speech Rights at Risk from Attacks on Medical Education,  April 12, 2006

•  It's The Law: Disgorgement and Restitution,  February 2006

•  What You Don't Know about AIP Can Hurt You,  November 2005

•  Just Sign on the Dotted Line?,  June 20, 2005

•  Exploring other options, Part 2: Facilitating the FDA review process,  June 2005

•  Exploring other options, Part 1: The trend toward alternative market pathways,  May 2005

•  FDA Must Reform Its Arbitrary Drug Name Review Process,  January 28, 2005

•  State Regulation of Pharmaceutical Clinical Trials,  2004

•  Western States Medical Center: A Watershed Moment for FDA's Regulation of Commercial Speech,  January/February 2003

•  Can FDA Seek Restitution or Disgorgement?,  2003

•  Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected Speech,  2003

Speaking Engagements    -    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

Blog Posts    -    see more blog entries
•  FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications?,  September 21, 2017
•  CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee Meetings,  September 13, 2017
•  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