Baxter’s Colleague moves ahead
This article was originally published in The Gray Sheet
Executive Summary
Firm announces conditional FDA approval on Dec. 14 of a corrective action plan for the Colleague drug infusion pump. The company also reported filing an updated 510(k) for the device. Upon agency clearance of the 510(k) and final approval of the corrective plan, Baxter will begin field upgrades to more than 200,000 pumps in U.S. hospitals. The pumps have been off the market for more than a year, following an October 2005 seizure by FDA. In June Baxter signed a consent decree with the agency requiring the firm to comply with manufacturing quality control regulations before U.S. sales can resume (1"The Gray Sheet" July 3, 2006, p. 4)...