FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: MICROBIOLOGY DEVICES; RECLASSIFICATION OF MYCOBACTERIUM TUBERCULOSIS CELL-MEDIATED IMMUNITY TESTS AND IMMUNE RESPONSE ENZYME-LINKED IMMUNOSPOT TESTS

WASHINGTON, March 30 -- Food and Drug Administration has issued a proposed rule called: Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests.

The proposed rule was published in the Federal Register on March 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosiscell-mediated immunity tests and Mycobacterium tuberculosiscell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosisinfection (product codes NCD and OJN, respectively), bot...