Summary: Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex (Final Rule)
This rule reclassifies nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex from class III (pre-market approval or PMA) to class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Regulatory Impact Analysis
Federal Register: 79 FR 31023-31028, May 30, 2014