FDA’s New Device Reclassification Process


FDA’s New Device
Reclassification Process:
How New Criteria May
Impact Your Device

Your office, May 22, 2014


Meet your instructors

Beth Bierman has more than 25 years of representing domestic and international companies regarding FDA policies with Morgan Lewis FDA Practice where she is a partner. She has worked on cases including the development, manufacturing, and marketing of medical devices, health information technology, pharmaceuticals, tissue products, combination products, medical foods, and infant formulas. She has instructed medical device companies on how FDA regulations will impact their business and production future.

Phoebe Mounts is a partner in Morgan Lewis FDA Practice with more than 16 years of professional experience regarding public health. She previously worked at John Hopkins University School of Public Health where she published more than 45 articles regarding molecular biology and infectious diseases. She assists clients who are dealing with preclinical studies, emerging technologies and technical manufacturing information.

Michele Buenafe is an associate in Morgan Lewis FDA Practice where she focuses on state and federal regulatory regulations, compliance, and enforcement issues related to medical devices, health IT, pharmaceuticals, controlled substances and human tissue products.