FDA ISSUES GUIDANCE ON RECLASSIFIED ANTIMICROBIAL SUSCEPTIBILITY TESTS

The FDA has published guidance supporting the reclassification of antimicrobial susceptibility test (AST) systems.

The AST systems are meant to determine the in vitro susceptibility of bacterial pathogens, disease-causing biological agents located in bacteria. Such tests may be used to analyze the efficacy of antibacterial substances. The guidance reclassifies AST systems from Class III into Class II (special controls) when the test involves incubation periods of less than 16 hours.

The guidance, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems," can be viewed at www.fda.gov/cdrh/oivd/guidance/631.pdf ( http://www.fda.gov/cdrh/oivd/guidance/631.pdf ).