M. Elizabeth Bierman represents US and international companies in US Food and Drug Administration (FDA) and state regulatory matters that impact the development, manufacturing, and marketing of their products. Beth has more 25 years of experience representing companies that produce a range of products regulated by the FDA, including medical devices, digital health products and mobile medical applications, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas. She also provides guidance on related jurisdictional issues and regulatory pathway strategies.
As part of her FDA regulatory counseling practice, Beth provides guidance on medical device labeling, promotional materials and other marketing activities. She works closely with clients to strategize on regulatory pathway issues and to prepare medical device submissions to the FDA, including 510(k)s, IDEs, HUDs, HDEs, requests for designation, and other regulatory submissions.
Counseling medical device companies on all aspects of FDA regulation that affect their businesses and products, Beth helps technology and device makers stay abreast of emerging legal issues relating to medical device data systems, mobile medical apps, clinical decision support software, and other health information technologies.
Beth also advises on postmarket compliance issues, including medical device reporting, product recalls, Quality System Regulation, and responses to FDA Form 483 requests and warning letters. She provides support in medical device litigation and counsels clients on state law issues relating to medical device distribution.
Beth speaks regularly on medical device law, including FDA regulatory issues applicable to health information technologies. She has served as a faculty member at the FDA’s staff college for training new review staff, and has published numerous articles on medical device and pharmaceutical regulatory issues.
Catholic University of America, Columbus School of Law, 1986, J.D.
University of Virginia, 1977, B.A.
District of Columbia
Awards and Affiliations
Recommended, Industry focus – Healthcare – life sciences, The Legal 500 US (2017)
Ranked, Who’s Who Legal: Life Sciences – Regulatory(2017)