01/28/15 Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents
U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk Devices” (General Wellness Guidance) and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” (Accessories Guidance).
10/30/14 Medical Device Update: Distinguishing Medical Device Recalls from Medical Device EnhancementsView all publications
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.
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.