{"abstract":"The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.","action":"Proposed amendment; proposed order; request for comments.","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/2026/03/30/2026-06064.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"91 FR 15572","comment_url":"http://www.regulations.gov/commenton/FDA-2026-N-2590-0001","comments_close_on":"2026-05-29","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments on the proposed order by May 29, 2026. Please see section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-2590"],"dockets":[{"supporting_documents":[{"title":"Reference 9 - Treatment of Drug-Susceptible Tuberculosis","document_id":"FDA-2026-N-2590-0012"},{"title":"Reference 8 - Diagnosis of Tuberculosis in Adults and Children","document_id":"FDA-2026-N-2590-0011"},{"title":"Reference 7 - 2023_ Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement","document_id":"FDA-2026-N-2590-0010"},{"title":"Reference 6 - 2011 Meeting Materials of the Microbiology Devices Panel","document_id":"FDA-2026-N-2590-0009"},{"title":"Reference 5 - P070006 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0008"},{"title":"Reference 4 - P180047 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0007"},{"title":"Reference 3 - P010033 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0006"},{"title":"Reference 2 - 2001 Microbiology Devices Panel Meeting Summary","document_id":"FDA-2026-N-2590-0005"},{"title":"Reference 1 - P010033 Approval Order","document_id":"FDA-2026-N-2590-0004"},{"title":"List of References_FDA-2026-N-2590","document_id":"FDA-2026-N-2590-0003"}],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2026-03-30","updated_at":"2026-05-13T01:57:05.265-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-2590-0001","allow_late_comments":false,"id":"FDA-2026-N-2590-0001","comment_end_date":"2026-05-30","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":10,"id":"FDA-2026-N-2590","title":"Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests"}],"document_number":"2026-06064","effective_on":null,"end_page":15582,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/30/2026-06064.xml","html_url":"https://www.federalregister.gov/documents/2026/03/30/2026-06064/microbiology-devices-reclassification-of-mycobacterium-tuberculosis-cell-mediated-immunity-tests-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-06064?publication_date=2026-03-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-30/2026-06064/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":1413,"last_updated":"2026-05-25 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-30/pdf/2026-06064.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06064.pdf?1774615515","publication_date":"2026-03-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/30/2026-06064.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 9 - Treatment of Drug-Susceptible Tuberculosis","document_id":"FDA-2026-N-2590-0012"},{"title":"Reference 8 - Diagnosis of Tuberculosis in Adults and Children","document_id":"FDA-2026-N-2590-0011"},{"title":"Reference 7 - 2023_ Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement","document_id":"FDA-2026-N-2590-0010"},{"title":"Reference 6 - 2011 Meeting Materials of the Microbiology Devices Panel","document_id":"FDA-2026-N-2590-0009"},{"title":"Reference 5 - P070006 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0008"},{"title":"Reference 4 - P180047 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0007"},{"title":"Reference 3 - P010033 Summary of Safety and Effectiveness Data","document_id":"FDA-2026-N-2590-0006"},{"title":"Reference 2 - 2001 Microbiology Devices Panel Meeting Summary","document_id":"FDA-2026-N-2590-0005"},{"title":"Reference 1 - P010033 Approval Order","document_id":"FDA-2026-N-2590-0004"},{"title":"List of References_FDA-2026-N-2590","document_id":"FDA-2026-N-2590-0003"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-2590","supporting_documents_count":10,"docket_id":"FDA-2026-N-2590","document_id":"FDA-2026-N-2590-0001","regulation_id_number":null,"title":"Microbiology Devices; Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests","checked_regulationsdotgov_at":"2026-05-14T04:55:13Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2026-N-2590-0001","significant":null,"signing_date":null,"start_page":15572,"subtype":null,"title":"Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests","toc_doc":"Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests","toc_subject":"Microbiology Devices","topics":["Biologics","Laboratories","Medical devices"],"type":"Proposed Rule","volume":91}