Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex
This rule proposes to reclassify nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex from class II (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: 78 FR 36698-36702, June 19, 2013