Jeff has 30 years’ experience in US medical device law and regulation.  He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, breakthrough designations, and internal agency appeals.  He helps firms develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA’s requests for information and data.  When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance.  His mission is to bring companies through the FDA process as efficiently and expeditiously as possible.  Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA’s regulation of combination products (e.g., drug-device combinations).

Jeff is a national authority on FDA’s regulation of medical devices, combination products, and HCT/Ps.  He actively contributes to industry conversations on FDA regulation of medical devices. He has published hundreds of articles on various topics relating to FDA’s regulation of medical devices.

He is a past member of the Editorial Advisory Board for both 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).  He has contributed chapters to several textbooks, including Medical Devices Law and Regulation Answer Book (Practising Law Institute 2023 ed.).

Jeff was a Lecturer and Fischell Literati teaching the University of Maryland’s Regulatory Law: Medical Devices course. He has served on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute.

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