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U.S. Department of Health and Human Services

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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

Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex (PDF – 96KB)

Federal Register: 79 FR 31023-31028, May 30, 2014

Docket: FDA-2013-N-0544