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 currently is a guest lecturer for the University of Maryland's Regulatory Law: Medical Devices course.
• 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, 2012-2014
• DC Super Lawyers, 2014
• Who's Who Legal: Life Sciences 2014
Articles / Publications
see more articles
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
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,
see more speaking engagements
RAPS Webinar - Updates on Medical Device Post-Market Reporting Regulations, July 22, 2014
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).
Updates on Medical Device Post-Market Reporting Regulations, July 22, 2014
Medical device reporting
Exploring Legal Challenges to Fulfilling the Potential of Health in a Safe and Responsible Environment, June 16 - 17 2014
Workshop on "Regulatory Landscape: Look Forward"
RAPS Medical Device Submission and Compliance conference, March 13 - 14, 2014
Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(k)s
Advertising and Labeling
FDLI Medical Device conference, February 27, 2014
Panelist for session on "FDA Guidances, CDRH's Appeals Process Guidance and the MDR Guidance"
see more blog entries
FDLI's 2014 Medical Device Conference - Key Legal and Regulatory Developments,
February 12, 2014
FDA Issues New Draft Guidance for Custom Devices; Some Points Worth Highlighting,
January 27, 2014
Free the FDAAA Hostage!,
October 7, 2013
Mobile Medical Applications: A Thoughtful Guidance Is Finalized,
September 26, 2013
Is the Malfunction MDR Reporting Requirement Unconstitutional?,
September 9, 2013