FDA Publishes Susceptibility Test System Guidance

Originally Published MDDI March 2003

NEWSTRENDS

In February, FDA announced the availability of the special controls guidance dealing with antimicrobial susceptibility testing. The guidance document is entitled Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. The special control guidance supports the reclassification of fully automated short-term incubation cycle antimicrobial susceptibility devices from class III to class II. FDA has also published a final rule reclassifying the fully automated short-term incubation cycle antimicrobial susceptibility device from class III to class II. 

The guidance describes the classification, product code, and classification definition of the relevant devices. It also defines the risks to health and serves as a special control that device manufacturers may find helpful in gaining a timely review and clearance of a 510(k) notification.

Copyright ©2003 Medical Device & Diagnostic Industry