In Brief: Microbiology Devices Panel

Executive Summary

Microbiology Devices Panel: FDA advisory panel unanimously votes (5-0) in favor of downclassification of automated short-term incubation cycle antimicrobial susceptibility devices from Class III to Class II at a Feb. 13 meeting in Rockville, Maryland. BioMerieux Vitek requested the downclassification in a petition submitted to the agency on July 24, 1997 ("The Gray Sheet" Aug. 18, I&W-6). Special controls recommended by the panel include an updated version of FDA's "Review Criteria for the Assessment of Antimicrobial Susceptibility Devices"...