Jeffrey K. Shapiro

• Assisted a client in obtaining a de novo clearance.
• Aided client's administrative appeal of a 510(k) clearance denial
• Helped a client persuade FDA that its product should be classified as a device rather than as a drug.
• Aided a client's response to an FDA warning letter alleging GMP non-compliance.

Jeff Shapiro is a nationally recognized authority on FDA’s regulation of medical devices, combination products, and HCT/Ps, with more than 30 years’ experience. He helps start-up, mid-sized, and global manufacturers get products to market and keep them there — building regulatory strategy, preparing presubmissions, 510(k)s, De Novo requests, PMAs, and breakthrough designations, pressing internal FDA appeals, and managing inspections, warning letters, recalls, and adverse event reporting.

Jeff advises across the full product life cycle and the full risk spectrum: digital health, AI/machine-learning-enabled software, in vitro diagnostics and laboratory developed tests, orthopedic and cardiovascular implants, drug-device combinations, and regenerative medicine products. He also handles jurisdictional and product classification disputes, labeling and promotional review, clinical trial and IDE issues, quality system and postmarket compliance, regulatory due diligence in M&A and financings, and litigation support as a testifying and consulting expert in patent, contract, and product cases. Before entering private practice, Jeff served as an Attorney Advisor in the U.S. Department of Justice’s Office of Legal Counsel. He earned his J.D. cum laude from Harvard Law School.

Jeff has published hundreds of articles on FDA’s regulation of medical devices and is a frequent commentator in Law360, MD+DI, and other industry press. He is a past member of the Editorial Advisory Board for MDDI and Update magazines, 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 a contributing chapter author to Medical Device Law and Regulation Answer Book (Practising Law Institute, 2023 ed.). He has taught FDA device regulation at the University of Maryland and George Washington University and served on the Food and Drug Law Institute’s Medical Devices and Diagnostics Committee. He is recognized as a Life Sciences Key Lawyer by The Legal 500, a Life Science Star by LMG Life Sciences, and a DC Super Lawyer.

Clients come to Jeff for candid, practical judgment on the questions that decide whether a product reaches the market — and how quickly.