{"abstract":"The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection 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 classification of the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. 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/2026/05/12/2026-09335.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"91 FR 25783","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective May 12, 2026. The classification was applicable on April 29, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4274"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2026-05-12T10:57:06.888-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4274-0001","allow_late_comments":false,"id":"FDA-2026-N-4274-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-4274","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection"}],"document_number":"2026-09335","effective_on":"2026-05-12","end_page":25785,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/12/2026-09335.xml","html_url":"https://www.federalregister.gov/documents/2026/05/12/2026-09335/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/2026-09335?publication_date=2026-05-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-12/2026-09335/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1627,"last_updated":"2026-05-18 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-12/pdf/2026-09335.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09335.pdf?1778503521","publication_date":"2026-05-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/12/2026-09335.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-2026-N-4274","supporting_documents_count":0,"docket_id":"FDA-2026-N-4274","document_id":"FDA-2026-N-4274-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection","checked_regulationsdotgov_at":"2026-05-13T18:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25783,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection","toc_doc":"Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers from Patients with Suspected Orthopedic Infection","toc_subject":"Medical Devices","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":91}