Morgan Lewis

Related Publications

08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process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.
08/06/14 Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged
On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key changes to FDA’s policies that may affect their 510(k) submissions, including new limitations on the use of multiple predicates, the unacceptability of split predicates, an increase in the content and detail required for 510(k) summaries, and FDA’s intent to “verify the accuracy and completeness” of 510(k) summaries.
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
View Printable List

M. Elizabeth Bierman

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
3 news articles found
page 1 of 1


Date Title Description
Oct 03, 2013 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.
Aug 27, 2013 Nestle, Dannon, Gerber Beat Baby Product Fluoride Suit, Law360
Morgan Lewis's representation of Dannon is covered.
Jul 13, 2011 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.

page 1 of 1