Zdrowie i gospodarka · 5.02.2003

Medical Devices: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." This guidance document was developed as a special control guidance to support the reclassification of the fully automated short-term incubation cycle antimicrobial susceptibility device from class III to class II. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying the fully automated short-term incubation cycle antimicrobial susceptibility device from class III to class II.