Home » FDA Should Consider Reclassifying TB Devices, Panel Recommends
FDA Should Consider Reclassifying TB Devices, Panel Recommends
The FDA’s Microbiology Devices advisory panel has unanimously recommended that the FDA consider down-classifying certain diagnostic tests for tuberculosis (TB) infections. Specifically, nucleic acid-based amplification tests for TB, such as Gen-Probe’s Amplified MBT (mycobacterium tuberculosis direct) test, should become a Class II device with a special controls guidance to help mitigate known risks.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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