Antimicrobial Susceptibility Device Downclassification Supported By Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's May 1991 draft guidance on "Review Criteria for the Assessment of Antimicrobial Susceptibility Devices" (ASDs) should be updated for use as a special control prior to downclassification of automated short-term incubation cycle (STIC) ASDs, the agency's Microbiology Devices Panel recommended Feb. 13.