08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process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.
07/31/14 FDA Releases Details of New Framework for Laboratory Developed Tests RegulationView all publications
FDA sends notice to Congress on LDTs.
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 ApaxView all news
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.