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 this classification downgrade, device sponsors will be able to bring devices to the market with both greater ease and less expense. In addition to the proposed rule, the FDA issued a draft guidance to aid in the transition from Class III to Class II. The…