Kitchens and Minsk Contribute to Medical Devices Law and Regulation Answer Book

In late August 2011, the Practising Law Institute headquartered in New York City published Medical Devices Law and Regulation Answer Book 2011–12, which provides, in a single resource, a guide to the complexities of Food and Drug Administration (FDA) regulation of medical devices. Among the book’s authors are Arnall Golden Gregory partners William H. Kitchens and Alan G. Minsk, who wrote the chapter on “Interacting with FDA.” Their chapter provides practical advice on how to handle interactions with the FDA on topics from what sort of precautions to take before addressing a question to the FDA to what are acceptable protocols if an issue needs to be escalated within the FDA.