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08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification ProcessView all publications
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.
12/04/14 Morgan Lewis Advises BTG in Acquisition of Medical Device Maker PneumRx
Morgan Lewis represented BTG plc as M&A counsel in its $475 million acquisition of PneumRx Inc., a venture-backed lung treatment specialist based in California
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 AwardsView all news
Morgan Lewis was named Healthcare Pricing and Reimbursement Firm of the Year at the inaugural LMG Life Sciences awards ceremony.