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