|Law Partner Brings PMA, Compliance Experience to MD&DI|
Jeffrey K. Shapiro has joined MD&DI's Editorial Advisory Board. Shapiro is a director at the law firm Hyman, Phelps, and McNamara. From 2000 to 2007, he was a partner with the firm Hogan & Hartson. Before that, Shapiro served in the office of legal counsel at the Department of Justice.
As a member of the Editorial Advisory Board, Shapiro adds considerable expertise to the magazine. His focus is primarily on assisting medical device and diagnostics manufacturers in complying with regulatory requirements such as obtaining premarket clearance, handling adverse-event reporting, maintaining quality systems, and responding to FDA-483s or warning letters. His expertise is on the legal aspects of mergers and acquisitions, combination products, and human and cellular tissue products.
A long-time contributing editor to MD&DI, Shapiro is also a coeditor of Promotion of Biomedical Products, a textbook on FDA regulations on promoting and advertising medical devices published by FDLI in 2007. He is also coauthor of “Combination Products: How to Develop the Optimal Strategic Path for Approval” for the Web site www.fdanews.com. He has written numerous articles in the Food and Drug Law Journal, Regulatory Affairs Focus, and FDLI Update.
Shapiro has a JD from Harvard Law School (1986), and he holds a BA from Brown University. He is a member of the Federalist Society.