U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Summary: Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex (Final Rule)
  1. Economic Impact Analyses of FDA Regulations

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

   
Back to Top