{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect or measure nucleic acid from viruses associated with head and neck cancers 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 device to detect or measure nucleic acid from viruses associated with head and neck cancers' 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/2024/09/16/2024-20896.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"89 FR 75491","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 16, 2024. The classification was applicable on May 11, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-4061"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-09-16T10:56:25.310-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-4061-0001","allow_late_comments":false,"id":"FDA-2024-N-4061-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-4061","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect or Measure Nucleic Acid from Viruses Associated with Head and Neck Cancers"}],"document_number":"2024-20896","effective_on":"2024-09-16","end_page":75493,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/16/2024-20896.xml","html_url":"https://www.federalregister.gov/documents/2024/09/16/2024-20896/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-or","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-20896?publication_date=2024-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-16/2024-20896/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":855,"last_updated":"2026-08-25 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20896.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20896.pdf?1726231525","publication_date":"2024-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/16/2024-20896.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-2024-N-4061","supporting_documents_count":0,"docket_id":"FDA-2024-N-4061","document_id":"FDA-2024-N-4061-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect or Measure Nucleic Acid from Viruses Associated with Head and Neck Cancers","checked_regulationsdotgov_at":"2024-09-17T14:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":75491,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers","toc_doc":"Immunology and Microbiology Devices; Classification of the Device to Detect or Measure Nucleic Acid from Viruses Associated with Head and Neck Cancers","toc_subject":"Medical Devices:\n","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":89}