Resources for Food and Drug Administration (FDA)

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems;Guidance for Industry and FDA

CDRH

This guidance document was developed as a special control guidance to support the reclassification of the antimicrobial susceptibility test (AST) system, when the device is a system employing short-term incubation (less than 16 hours) from class III into class II (special controls). The device is intended to determine the in vitro susceptibility of bacterial pathogens from clinical specimens. This guidance was originally issued March 8, 2000, in conjunction with a Federal Register notice announcing the reclassification of the automated short-term incubation cycle AST system. Following the effective date of that final reclassification rule any firm submitting a 510(k) premarket notification for a automated short-term incubation cycle AST system needs to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

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