King & Spalding announced today that Jeff Shapiro, a nationally recognized medical device lawyer, has joined the firm’s Government Matters practice group as a partner. Shapiro is based in Washington, D.C. Shapiro joins the firm from Washington-based FDA law firm Hyman, Phelps & McNamara, where he was a director. 

Shapiro has advised and represented medical device companies before the U.S. Food and Drug Administration (FDA) for more than 25 years. He has extensive experience in FDA product clearances and approvals, regulatory pathway strategies, medical device reporting and Part 806 reporting requirements, labeling and advertising, recalls, responding to FDA inspections and warning letters, and regulation of combination products. He helps start-up, mid-sized, and large medical device manufacturers develop pre-market strategies and achieve post-market compliance.

“Jeff has developed an excellent reputation in the FDA legal community and a strong client base in the medical device space, and we are very excited for how he will help expand our client services and capabilities in this key area of our globally recognized FDA practice,” said Mark Brown, leader of the firm’s FDA and Life Sciences team. “He brings a strong focus on teamwork, problem solving, and client service that makes him an ideal fit for our practice and our firm.”

He earned his undergraduate degree from Brown University and his J.D. from Harvard Law School.

“King & Spalding has a stellar reputation for FDA regulatory work, and its strong, solutions-oriented focus on its clients and its high-performing platform are really appealing to me,” Shapiro said. “I am energized about the prospect of working with my colleagues here to expand the firm’s pre-market regulatory practice and how we can collaborate to better serve the diverse needs of medical device companies.”