FDA v. Laerdal
This article was originally published in The Gray Sheet
Executive Summary
U.S. District Court for the District of Oregon denies FDA request to enjoin Laerdal from production and distribution of its external defibrillators. The court found that "in light of the changes in the quality assurance procedures" made by Laerdal after FDA filed its action, the agency "has not proven by a preponderance of the evidence" that Laerdal violates GMP regulations. However, in its May 26 order, the court granted an FDA request to enjoin Laerdal from "failing or refusing to furnish" medical device reporting information