Tag Archive: Tuberculosis

Apr 06

FDA Proposes Reclassification of Tuberculosis Tests

On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, are used in the detection of tuberculosis (“TB”) from a patient’s mucus (sputum) sample. With …

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