Summary: Regulatory Impact Anaylsis of 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.
- 77 FR 16126-16129, March 19, 2012
- Docket Number: FDA-2012-N-0159