IVD office update
This article was originally published in The Gray Sheet
Executive Summary
CDRH Division of Clinical Laboratory Devices will be supplanted this fall upon creation of the Office for In Vitro Diagnostic Device Evaluation and Safety, DCLD staffers indicate. The office, which will be located in the same space currently occupied by DCLD, will also incorporate staffers from the In Vitro Diagnostics Devices Branch from the device center's Office of Compliance as well as a handful of personnel from CDRH's other offices. The office aims to maximize efficiencies by consolidating IVD premarket, compliance and postmarket resources and expertise (1"The Gray Sheet" Sept. 9, 2002, p. 15)...