Hyman Phelps and McNamara
Jeffrey K. Shapiro
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(202) 737-9633
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Attorney C.V.

Practice Areas
Medical Devices
Corporate Transactions

J.D., cum laude, Harvard Law School
A.B., magna cum laude, Brown University

Bar Admissions
District of Columbia

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Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 20 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters. Mr. Shapiro also counsels clients on FDA requirements governing IVDs and HCT/Ps. Mr. Shapiro is an expert in FDA's regulation of combination products, including preparation of RFDs. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Mr. Shapiro recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies.

Mr. Shapiro actively contributes to industry conversations on medical device regulations. He is a member of the Editorial Advisory Board for both MDDI and Update magazines, and co-editor of two textbooks, Promotion of Biomedical Products (Food and Drug Law Institute, 2006) and Combination Products, How to Develop the Optimal Strategic Path for Approval (FDA News 2005), and is a frequent speaker and contributor to the firm's FDA Law Blog, among other publications. Mr. Shapiro was a Lecturer and Fischell Literati teaching the University of Maryland's Regulatory Law: Medical Devices course. He currently serves on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute.

Related Experience
Medical Devices
• Develops premarket regulatory strategies for products.
• Assists with IDE, 510(k) clearance, and PMA submissions.
• Handles appeals of premarket decisions, such as NSE letters.
• Advises in MDR, recall (field action), and QSR compliance matters.
• Reviews labeling and advertising for compliance.
• Performs regulatory due diligence and post acquisition risk mitigation.
• Reviews contracts and security disclosure documents.
• Provides advice regarding jurisdictional disputes with FDA.
• Facilitates the transfer of 510(k)/PMA.
• Responds to Form 483s and warning letters.
• Provides advice regarding the regulation of IVD, LDT, IUO and RUO products.

In Vitro Diagnostic Devices
• Helps clients develop regulatory strategies for clearance and approval.
• Provides guidance on laboratory developed tests (LDTs).
• Provides advice on requirements for RUO and/or IUO status.
• Assists with post-market compliance.

HCT/P, Tissue Products
• Advises on whether products qualify for regulation solely as HCT/Ps under 21 CFR Part 1271.
• Provides counsel on GTPs, adverse reaction reporting and HCT/P deviation reporting.

Awards & Recognition
• Life Science Star, LMG Life Sciences, 2012-2017
• Nominee for Regulatory Attorney of the Year, LMG Life Sciences, 2017
• DC Super Lawyers, 2014-2017
• The International Who's Who of Business Lawyers (Life Sciences), 2014-2017

Articles / Publications    -    see fewer articles
•  When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm,  September 19, 2017

•  Is the 510(k) process as worthless as the federal courts seem to believe?,  August 8, 2017

•  The Problem of the ‘Intended Use’ Regulations Continues to Fester,  March 21, 2017

•  A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts,  November 29, 2016

•  Promoting Your 510(k) - Pending Device: 5 Questions About FDA's Policy,  October 12, 2016

•  Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future? The Short Answer: No,  April 2016

•  Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products,  March 31 2016

•  Hyman, Phelps & McNamara jointly with Barton and Blank present the webinar: Medical Device Promotion on Social Media,  October 21, 2014

•  Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices,  September 12, 2014

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

•  Substantial Equivalence Review of Medical Devices,  May 4, 2013

•  New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked,  April 22, 2013

•  The US FDA and its Draft Guidance on Medical Device Appeals,  April 2013

•  US FDA should be required to provide 510(k) decision summaries for devices - a missed opportunity by lawmakers,  July 2012

•  FDA Appeals - Improving Your Odds of Success: Trends, Expectations, Strategies,  March 21, 2012

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

•  What Happens to Medical Device Reports Once They Reach FDA?,  January 2011

•  The Family Smoking Prevention and Tobacco Control Act: An Overview,  December 2009

•  Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers,  June 2008

•  The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA,  May/June 2008

•  FDA's Regulatory Scheme for Human Tissue,  November/December 2007

•  Condition of Approval Studies: FDA Takes A New Look,  August 2005

•  Federal and State Requirements for HCT/Ps: An Overview,  May 2005

•  Comparative Claims: Legally Permissible, But Proceed with Care,  September 2004

•  FDA's Regulation of Combination Products: The Road Ahead,  November 2003

•  When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel,  June 2003

•  FDA's Regulation of Analyte-Specific Reagents,  February 2003

•  Promoting Devices for Specific Indications Based Upon a General Clearance,  February 2003

•  Medical Device Reporting: A Risk-Management Approach,  January 2003

•  FDA's Regulation of Internet Promotion and Advertising,  July 2001

•  The Washington Legal Foundation Litigation and Its Aftermath,  February 2001

•  How to Transfer Ownership of a 510(k) Clearance,  April 2000

•  Displaying Investigational and Unapproved Medical Devices According to FDA Policy,  October 1997

Speaking Engagements    -    see more speaking engagements
•  Florida Medical Device Symposium, Off Label Promotion of Medical Devices, May 8-9, 2017
•  21st Century Cures Act and its Effect on FDA’s Regulation of Devices and Combination Products, January 18, 2017
•  FDLI Advertising and Promotion Conference, Trends and Special Issues for Device Promotion, September 27-28, 2016
•  Florida Medical Device Symposium, Off-Label Promotion of Medical Devices, May 9-10, 2016
•  FDLI's Enforcement, Litigation and Compliance Conference, Medical Devices Mobile Health (mHealth), December 10, 2015

Blog Posts    -    see more blog entries
•  When It Comes to Software As A Medical Device (SAMD), FDA Acknowledges that New Technology No Longer Fits The Old Regulatory Paradigm ,  August 6, 2017
•  Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?,  July 11, 2017
•  Proposed Changes to the Device Intended Use Regulation,  April 2, 2017
•  A New Rulemaking Is Needed for the Intended Use Regulation,  March 9, 2017
•  How To Get Rid of The “Totality of the Evidence” Amendment to The Intended Use Regulation,  March 7, 2017