Morgan Lewis

Related Publications

10/30/14 Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements
The final guidance clarifies when a change to a device constitutes a medical device recall, distinguishes device recalls from device enhancements, and clarifies reporting requirements under 21 C.F.R. Part 806.
08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process
The draft provides guidance on a streamlined process for submitting requests to the FDA to down-classify certain low-to-moderate-risk devices that have been automatically classified as Class III.
View all publications

Related News

09/29/14 LMG Life Sciences Praises Morgan Lewis’s Life Sciences Capabilities
Morgan Lewis announces that the firm’s strength in the life sciences industry has been recognized on numerous occasions recently in the Legal Media Group’s LMG Life Sciences 2014 legal guides.
10/03/13 Morgan Lewis Receives 2013 LMG Life Sciences Awards
Morgan Lewis was named Healthcare Pricing and Reimbursement Firm of the Year at the inaugural LMG Life Sciences awards ceremony.
08/27/13 Nestle, Dannon, Gerber Beat Baby Product Fluoride Suit, Law360
Morgan Lewis's representation of Dannon is covered.
View all news
Photo of  M. Elizabeth Bierman

practice accolades

FDA

Named the Healthcare Pricing and Reimbursement Firm of the Year by LMG Life Sciences (2013)

Ranked the second-largest U.S. healthcare law firm by Modern Healthcare (2012–2013)

Recognized as a top 10 law firm within the Life Sciences Regulatory Super League by The Practical Law Company (PLC) (2012)

Listed as Recommended in PLC's Life Sciences Multi-Jurisdictional Guide (2012)

honors + affiliations

Listed, Legal Media Group's Life Sciences "Life Sciences Star" – Regulatory (2013–2014)

bar admissions

  • District of Columbia
print profile

M. Elizabeth Bierman
Partner


Email: mebierman@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States of America
Phone: +1.202.739.5206
Fax: +1.202.739.3001

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.

education

  • Catholic University of America, Columbus School of Law, 1986, J.D.
  • University of Virginia, 1977, B.A.