{"abstract":"The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled \"Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.\" These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/05/30/2014-12544.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"79 FR 31023","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 30, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0544"],"dockets":[],"document_number":"2014-12544","effective_on":"2014-06-30","end_page":31028,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/30/2014-12544.xml","html_url":"https://www.federalregister.gov/documents/2014/05/30/2014-12544/microbiology-devices-reclassification-of-nucleic-acid-based-systems-for-mycobacterium-tuberculosis","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-12544?publication_date=2014-05-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-30/2014-12544/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":326,"last_updated":"2026-10-25 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/2014-12544.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-12544.pdf?1401368061","publication_date":"2014-05-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/30/2014-12544.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic\nDevices for the Detection of Mycobacterium tuberculosis Complex in\nRespiratory Specimens re Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium ","document_id":"FDA-2013-N-0544-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0544","supporting_documents_count":1,"docket_id":"FDA-2013-N-0544","regulation_id_number":null,"title":"Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium Tuberculosis Complex in Respiratory Specimens","checked_regulationsdotgov_at":"2014-06-19T06:00:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31023,"subtype":null,"title":"Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens","toc_doc":"Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens; Reclassification","toc_subject":"Microbiology Devices:","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":79}