Morgan Lewis

Related Publications

07/22/14 Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have analyzed some of the more significant guidances that were issued in the second quarter of 2014 (April–June).
06/24/14 FDA to Cease Active Regulation of MDDS and Other Health IT Devices
The draft guidance also enables some health IT manufacturers to avoid the device tax.
View all publications

Related News

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.
07/13/11 Morgan Lewis Team Advises Kinetic Concepts on Company’s $6.3 Billion Acquisition by Apax
Morgan Lewis advised Kinetic Concepts, Inc. (KCI), on a definitive merger agreement under which a consortium comprised of private equity funds will acquire KCI in a $6.3 billion transaction.
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)

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, pharmaceuticals, tissue products, combination products, 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 had 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.