{"abstract":"The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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 real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. 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/2026/06/01/2026-10907.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"868","title":21}],"citation":"91 FR 32338","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 1, 2026. The classification was applicable on October 18, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-5722"],"dockets":[],"document_number":"2026-10907","effective_on":"2026-06-01","end_page":32340,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/01/2026-10907.xml","html_url":"https://www.federalregister.gov/documents/2026/06/01/2026-10907/medical-devices-anesthesiology-devices-classification-of-the-real-time-ultrasound-anatomy","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-10907?publication_date=2026-06-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-01/2026-10907/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":345,"last_updated":"2026-06-15 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-01/pdf/2026-10907.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10907.pdf?1780058727","publication_date":"2026-06-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/01/2026-10907.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"comments_count":0,"agency_id":"FDA","document_id":"FDA-2026-N-5722-0001","checked_regulationsdotgov_at":"2026-06-09T16:07:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32338,"subtype":null,"title":"Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia","toc_doc":"Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}