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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FDA's May 1991 draft guidance on "Review Criteria for the Assessment of Antimicrobial Susceptibility Devices" (ASDs) should be updated for use as a special control prior to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.

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FDA will likely not require additional post-market surveillance from companies manufacturing automated short-term incubation cycle (STIC) antimicrobial susceptibility devices (ASDs), the agency says in the March 8 Federal Register.

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