Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ribonucleic Acid Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and Purification Systems for Real Time Polymerase Chain Reaction Used in Molecular Diagnostic Testing); Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing)." This guidance document describes a means by which Ribonucleic Acid (RNA) preanalytical systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify RNA preanalytical systems into class II (special controls). This guidance document is immediately in effect as the special control for RNA preanalytical systems but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).