M. Elizabeth Bierman is a partner in Morgan Lewis's FDA Practice. Ms. Bierman has more than 25 years of experience in representing domestic and international companies with respect to all FDA and state regulatory compliance and enforcement matters relating to the development, manufacturing, and marketing of medical devices, health information technology, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas.
Ms. Bierman has counseled medical device companies on all aspects of FDA regulation affecting their business and products. She has advised on jurisdictional issues and regulatory pathway strategies for FDA-regulated products; advised technology and device companies on the FDA regulatory status and emerging legal issues related to medical device data systems, mobile medical apps, clinical decision support software, and other health information technology; assisted in preparing medical device product applications (e.g., 510(k)s, IDEs, HUDs, HDEs), requests for designation, and other regulatory submissions; conducted FDA regulatory due diligence; counseled on medical device labeling and promotional materials and activities; advised on medical device postmarket compliance issues (Medical Device Reporting, recalls, Quality System Regulation, responses to 483s, and Warning Letters); and provided regulatory support in litigation involving medical device manufacturers. She also has counseled clients on state law issues related to the distribution of medical devices.
Ms. Bierman has spoken and taught at medical device industry conferences on the fundamentals of medical device law and FDA regulatory issues applicable to health information technology, and has served on the faculty of FDA’s staff college for training new review staff. She also has written articles for domestic and international publications regarding medical device and pharmaceutical regulatory issues.
Ms. Bierman received her J.D. from Catholic University of America, Columbus School of Law and her B.A. from the University of Virginia.
Ms. Bierman is admitted to practice in the District of Columbia.
