Jeffrey K. Shapiro
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.
• 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,
• 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,
• US FDA should be required to provide 510(k) decision summaries for devices - a missed opportunity by lawmakers,
• 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,
• What Happens to Medical Device Reports Once They Reach FDA?,
• The Family Smoking Prevention and Tobacco Control Act: An Overview,
• Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers,
• The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA,
• FDA's Regulatory Scheme for Human Tissue,
• Condition of Approval Studies: FDA Takes A New Look,
• Federal and State Requirements for HCT/Ps: An Overview,
• Comparative Claims: Legally Permissible, But Proceed with Care,
• FDA's Regulation of Combination Products: The Road Ahead,
• When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel,
• FDA's Regulation of Analyte-Specific Reagents,
• Promoting Devices for Specific Indications Based Upon a General Clearance,
• Medical Device Reporting: A Risk-Management Approach,
• FDA's Regulation of Internet Promotion and Advertising,
• The Washington Legal Foundation Litigation and Its Aftermath,
• How to Transfer Ownership of a 510(k) Clearance,
• Displaying Investigational and Unapproved Medical Devices According to FDA Policy,
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
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