{"abstract":"The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device 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 whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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/2026/09/10/2026-18426.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"880","title":21}],"citation":"91 FR 57507","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 10, 2026. The classification was applicable on September 1, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-9909"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-10","updated_at":"2026-09-10T09:57:57.796-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-9909-0001","allow_late_comments":false,"id":"FDA-2026-N-9909-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-9909","title":"Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device"}],"document_number":"2026-18426","effective_on":"2026-09-10","end_page":57509,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/10/2026-18426.xml","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18426/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-whole-room-microbial","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-18426?publication_date=2026-09-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-10/2026-18426/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1142,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18426.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18426.pdf?1788957911","publication_date":"2026-09-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/10/2026-18426.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-9909","supporting_documents_count":0,"docket_id":"FDA-2026-N-9909","document_id":"FDA-2026-N-9909-0001","regulation_id_number":null,"title":"Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device","checked_regulationsdotgov_at":"2026-09-11T16:55:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57507,"subtype":null,"title":"Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device","toc_doc":"General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}