Jeffrey K. Shapiro Director 202-737-9633
Jeffrey K. Shapiro


Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 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.

Education & Admissions


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


District of Columbia


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.

Honors & Awards

  • Life Science Star LMG Life Sciences 2012-2021
  • DC Super Lawyers 2014-2021
  • The International Who’s Who of Business Lawyers Life Sciences 2014-2021

Speaking Engagements

  • Florida Medical Device Symposium, The New FDORA Statute: Pre-Approved Change Control Plans and Cyber Security of Devices, May 2-3, 2023
  • FDLI Virtual Event, Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA, What Regulatory Pathway Applies to My Digital Health Product? What Are Other Relevant Considerations?, November 9, 2021
  • FDLI Virtual Event, Advertising and Promotion for Medical Products Conference, Drug and Device Uses of Digital Health Tools: Considerations for Advertising and Promotion, October 13-15, 2021
  • FDLI Digital Health Technology and Regulation During COVID-19 and Beyond, Moderator, Regulation and Utilization of Digital Health in Clinical Trials, September 10, 2020
  • FDLI Introduction to Medical Device Law and Regulation, Premarket Notification 510(k) and De Novo Requests, April 7-8, 2020
  • Moderator, FDLI Webinar: What are FDA’s Tools for Responding to the Public Health Emergencies Such as the Coronavirus (COVID-19)?, March 19, 2020
  • FDLI Advertising and Promotion for Medical Products Conference, Case Study on Device Advertising and Promotion, October 17, 2019
  • Conference Chair, FDLI: Medical Devices: FDA Regulations in the Era of Technology and Innovation, June 6, 2019
  • FDA Boot Camp, Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations, March 25-27, 2019
  • FDLI Advertising and Promotion Conference for the Drug, Medical Device, and Veterinary Industries, Consistent with Labeling Final Guidance: Implications for Devices, October 16-17, 2018
  • Florida Medical Device Symposium, Devices, May 14-15, 2018
  • Food and Drug Law Institute Annual Conference:  Exploring Advanced Topics in Food and Drug Law, Moderator, Lunch Table Discussionon Digital Health, May 3-4, 2018
  • FDLI’s Introduction to US Drug, Device, and Biologics Law and Regulation, Medical Devices – Advanced Topics, April 9-10, 2018
  • 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

Articles & Publications