{"abstract":"The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy 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 phase-changing fiducial marker for radiation therapy. 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/2026/07/29/2026-15303.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"892","title":21}],"citation":"91 FR 47788","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective July 29, 2026. The classification was applicable on December 23, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-7955"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-07-29","updated_at":"2026-07-29T11:56:31.460-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-7955-0001","allow_late_comments":false,"id":"FDA-2026-N-7955-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-7955","title":"Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy"}],"document_number":"2026-15303","effective_on":"2026-07-29","end_page":47790,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/29/2026-15303.xml","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-15303?publication_date=2026-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-29/2026-15303/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1004,"last_updated":"2026-09-20 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15303.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15303.pdf?1785242715","publication_date":"2026-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/29/2026-15303.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-7955","supporting_documents_count":0,"docket_id":"FDA-2026-N-7955","document_id":"FDA-2026-N-7955-0001","regulation_id_number":null,"title":"Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy","checked_regulationsdotgov_at":"2026-08-13T17:55:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47788,"subtype":null,"title":"Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy","toc_doc":"Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy","toc_subject":"Medical Devices","topics":["Medical devices","Radiation protection","X-rays"],"type":"Rule","volume":91}