Microbiology Devices Panel of the Medical Devices Advisory Committee

Microbiology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.

Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.