About Jeffrey Shapiro

Jeffrey Shapiro has more than 30 years of experience in US medical device law and regulation. He counsels firms in regulatory strategy and filings, including pre-submissions, clearances, approvals, breakthrough designations and internal agency appeals. He helps clients develop a sound regulatory strategy for bringing their devices through FDA review, to draft the relevant submissions, and to respond to the FDA’s requests for information and data. Jeffrey focuses on guiding companies through the FDA process as efficiently and expeditiously as possible as well as on counselling companies on post-market compliance. He is also a leading authority on the FDA’s regulation of combination products.