Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens." This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens from class III into class II. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis. This draft guidance document describes a means by which in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens may comply with the requirement of special controls for class II devices.