FDA's Office of Surveillance and Biometrics
This article was originally published in The Gray Sheet
Executive Summary
Device center office disbands its Division of Biometric Sciences in a restructuring effective Aug. 1. Two of the division's three branches, epidemiology (eight members) and postmarket studies (6 members), have been moved to OSB's Division of Postmarket Evaluation. The Statistics Branch (19 members) has been elevated to division status, with branch chief Harry Bushar acting as director for a 90-day detail. Creation of the Biostatistics Division, according to FDA staffers, anticipates the need for a larger statistics staff under a device user fee program. The entire restructuring must be finalized by center Director Bruce Burlington, which could occur within the next three months