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  6. Summary: Regulatory Impact Anaylsis of Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex
  1. Economic Impact Analyses of FDA Regulations

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.

 

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