{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target 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 device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target 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/2024/08/16/2024-18266.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"89 FR 66552","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective August 16, 2024. The classification was applicable on March 17, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3655"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-08-16T09:57:37.723-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3655-0001","allow_late_comments":null,"id":"FDA-2024-N-3655-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-3655","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Nucleic Acid Targets including SARS-CoV-2 in Respiratory Specimens"}],"document_number":"2024-18266","effective_on":"2024-08-16","end_page":66556,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/16/2024-18266.xml","html_url":"https://www.federalregister.gov/documents/2024/08/16/2024-18266/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-18266?publication_date=2024-08-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-16/2024-18266/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1161,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-16/pdf/2024-18266.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18266.pdf?1723725931","publication_date":"2024-08-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/16/2024-18266.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-3655","supporting_documents_count":0,"docket_id":"FDA-2024-N-3655","document_id":"FDA-2024-N-3655-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Nucleic Acid Targets including SARS-CoV-2 in Respiratory Specimens","checked_regulationsdotgov_at":"2024-08-17T13:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66552,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens","toc_doc":"Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARSCoV2 in Respiratory Specimens","toc_subject":"Medical Devices:\n","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":89}