Draft Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices.'' This draft guidance is neither final nor is it in effect at this time. This guidance document would serve as a special control for the reclassification of fully automated short-term incubation cycle antimicrobial susceptibility devices from class III to class II.