• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

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.


Federal Register