Laerdal injunction requiring defibrillator MDR reporting compliance upheld on appeal.
This article was originally published in The Gray Sheet
Executive Summary
LAERDAL INJUNCTION REQUIRING DEFIBRILLATOR MDR COMPLIANCE UPHELD by the U.S. Court of Appeals for the Ninth Circuit in an Oct. 25 ruling. The ruling, which relates to Laerdal's automatic external defibrillators, affirms the previous decision of the U.S. District Court of Oregon enjoining the company from "failing or refusing to furnish information required" by FDA under medical device reporting (MDR) regulations.