{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis 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 that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. We are taking this action because we have determined that classifying the device into class II 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, in part by reducing regulatory burdens.","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/2025/08/21/2025-16030.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"90 FR 40726","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective August 21, 2025. The classification was applicable on October 28, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-2106"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-08-21T09:56:29.810-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-2106-0001","allow_late_comments":false,"id":"FDA-2025-N-2106-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-2106","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device that Detects Nucleic Acid Sequences from Microorganisms Associated with Vaginitis and Bacterial Vaginosis"}],"document_number":"2025-16030","effective_on":"2025-08-21","end_page":40728,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/08/21/2025-16030.xml","html_url":"https://www.federalregister.gov/documents/2025/08/21/2025-16030/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-that-detects","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-16030?publication_date=2025-08-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-08-21/2025-16030/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":122,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-21/pdf/2025-16030.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16030.pdf?1755693937","publication_date":"2025-08-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/08/21/2025-16030.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-2025-N-2106","supporting_documents_count":0,"docket_id":"FDA-2025-N-2106","document_id":"FDA-2025-N-2106-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device that Detects Nucleic Acid Sequences from Microorganisms Associated with Vaginitis and Bacterial Vaginosis","checked_regulationsdotgov_at":"2025-08-22T16:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40726,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis","toc_doc":"Immunology and Microbiology Devices; Classification of the Device that Detects Nucleic Acid Sequences from Microorganisms Associated with Vaginitis and Bacterial Vaginosis","toc_subject":"Medical Devices","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":90}