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, 2012-2016
• DC Super Lawyers, 2014-2016
• The International Who's Who of Business Lawyers (Life Sciences), 2014-2016
Articles / Publications
see more articles
• 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
see fewer speaking engagements
• 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
• 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
• UDI Webinar, September 10, 2015
• AdvaMed FDA Inspections, Warning Letters and CAPA Workshop, 9/2 Speech: "Interactive Session: How to Respond to 483s and Warning Letters", September 1-2, 2015
• Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices, Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices, October 21, 2014
• Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices Webinar, Jeff Shapiro is co-presenting a Webinar on Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices, October 21, 2014
• RAPS Webinar - Updates on Medical Device Post-Market Reporting Regulations, Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803)., July 22, 2014
• Updates on Medical Device Post-Market Reporting Regulations, Medical device reporting, July 22, 2014
• Exploring Legal Challenges to Fulfilling the Potential of Health in a Safe and Responsible Environment, Workshop on "Regulatory Landscape: Look Forward", June 16 - 17 2014
• RAPS Medical Device Submission and Compliance conference, Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(k)s
Advertising and Labeling, March 13 - 14, 2014
• FDLI Medical Device conference, Panelist for session on "FDA Guidances, CDRH's Appeals Process Guidance and the MDR Guidance", February 27, 2014
• FDLI's 2014 Medical Device Conference - Key Legal and Regulatory Developments, Medical Device Reporting (MDR) requirements and the Appeals Process., February 12, 2014
• Advmed Advertising and Promotion Workshop, Review of Recent Compliance, November 13- 14, 2013
• FX Conferences, MDR Guidance webinar, October 3, 2013
• RAPS: The Regulatory Convergence, Advertising, Promotion and Labeling, September 29, 2013
• FXConferences, FxTrans Promotion Webinar, May 9, 2013
• Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School's annual conference:, Why the 510(k) Pathway is the Right Approach for Most Medical Devices, May 2 - 4, 2013
• RAPS Medical Device Submission & Compliance Strategies for the US Market Workshop, Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s
Advertising & Labeling, March 7 - 8, 2013
• Real-World Implications of United States v. Caronia, January 31, 2013
• Audioconference: When a 510(k) or PMA Goes Off Track - FDA's Appeals Process, January 10, 2013
• AdvaMed/MTLI Advertising and Promotion Workshop, Review of Recent Compliance Issues, November 7, 2012
• ACI: FDA Boot Camp Devices Edition, Fundamentals of FDA Regulatory Device Law
Overview of Device Regulation, October 23 - 25, 2012
• Orthopedic Surgical Manufacturer's Association Fall Meeting on, Advertising and Promotion, October 18, 2012
• Changes to the FDA's 510(k) Clearance Process Webinar, August 8, 2012
• Elsevier Business Intelligence Webinar, Discovering the Impact of the FDA's Eagerly Awaited Final Risk-Benefit Guidance, June 19, 2012
• AdvaMed Medical Device Workshop on FDA Inspections, Warning Letters & CAPA, Interactive Session: How to Respond to 483s and Warning Letters, May 22 - 23, 2012
• FDLI 55th Annual Conference, FDA Center Director's Roundtable Panel, April 24 - 25, 2012
• FDA Appeals - Improving Your Odds of Success; Trends, Expectations, Strategies, March 21, 2012
• RAPS Medical Device Submission & Compliance Strategies for the US Market Workshop, 1) Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s
2) Advertising & Labeling, March 5 - 7, 2012
• AdvaMed: Avoiding A Warning Letter, The Evolution of Expectations Over Time, December 8 - 9, 2011
• AdvaMed Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing, Recent Update of Compliance Issues, November 2, 2011
• Thompson Webinar, Combination Products: Classification, Regulations, and Guidances, October 18, 2011
• RAPS Webcast: Advertising, Promotion and Labeling - Marketing in a Regulated Environment, September 8, 2011
• Clinical and Regulatory Strategies for Combination Products Conference, Introduction to the Combination Product Sector, July 11 - 12, 2011
• FX Conferences Audio Conference, When a 510(k) or PMA Goes Off Track - FDA's Appeals Process, June 21, 2011
• RAPS Medical Device Submission & Compliance Strategies for the US Market Conference, Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)
Advertising and Labeling, June 7 - 9, 2011
• Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, When a 510K or PMA Goes Off Track: What Are the Options for Appeal, April 28, 2011
• ACI's Drug and Device Product Recalls Summit, Communicating Effectively with the FDA and collaborating with the Agency When Implementing a Recall, March 21 - 22, 2011
• Physicians and Physician Organizations Law Institute, Legal Issues in Physician-Owned Device Companies, February 9 - 10, 2011
• RAPS webinar and simulcast, Updates on the FDA 510(k) Clearance Process, December 2, 2010
• ACI: FDA Enforcement Summit - Fortifying Regulatory and Compliance Practices in the New Era of Aggressive Enforcement, Effectively Responding to Warning Letters and Protecting Your Company's Interests, May 24, 2010
• RAPS DC/Baltimore Chapter, Current Developments on the 510(k) Process, April 8, 2010
• Virginia CLE Webcast on Enforcement Powers and Practices of the U.S. Food and Drug Administration, August 5, 2009
• FDLI Audio Conference Moderator on Human Tissue Regulation, June 29, 2009
• Clinical Device Group Webinar, FDA Inspections of Sponsors or Manufacturers, March 18, 2009
• Moderator of ACI Forum Panel on TV, Radio, Print and "New Media": Identifying Legal and Business Parameters for DTC Marketing of Medical Devices, November 17 - 18, 2008
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