{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the human leukocyte antigen typing companion diagnostic test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the human leukocyte antigen typing companion diagnostic test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.","action":"Final amendment; final order.","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/2022/12/27/2022-28035.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"87 FR 79251","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 27, 2022. The classification was applicable on November 28, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0851"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-12-27","updated_at":"2023-02-27T21:00:11.311-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0851-0053","allow_late_comments":null,"id":"FDA-2021-N-0851-0053","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-N-0851","title":"Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests"}],"document_number":"2022-28035","effective_on":"2022-12-27","end_page":79253,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/12/27/2022-28035.xml","html_url":"https://www.federalregister.gov/documents/2022/12/27/2022-28035/medical-devices-immunology-and-microbiology-devices-classification-of-the-human-leukocyte-antigen","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-28035?publication_date=2022-12-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-12-27/2022-28035/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":577,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-27/pdf/2022-28035.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-28035.pdf?1671803125","publication_date":"2022-12-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/12/27/2022-28035.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0851","supporting_documents_count":0,"docket_id":"FDA-2021-N-0851","document_id":"FDA-2021-N-0851-0053","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests","checked_regulationsdotgov_at":"2023-02-28T02:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":79251,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Human Leukocyte Antigen Typing Companion Diagnostic Test","toc_doc":"Immunology and Microbiology Devices; Classification of the Human Leukocyte Antigen Typing Companion Diagnostic Test","toc_subject":"Medical Devices:\n","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":87}