{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software 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 radiological computer-assisted detection and diagnosis software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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/2025/06/13/2025-10789.html","cfr_references":[{"chapter":null,"citation_url":null,"part":892,"title":21}],"citation":"90 FR 24969","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 13, 2025. The classification was applicable on May 24, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-1529"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-13","updated_at":"2025-06-13T09:56:51.718-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-1529-0001","allow_late_comments":false,"id":"FDA-2025-N-1529-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-1529","title":"Medical Devices; Radiology Devices; Classification of the Radiological Computer Assisted Detection and Diagnosis Software"}],"document_number":"2025-10789","effective_on":"2025-06-13","end_page":24971,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/13/2025-10789.xml","html_url":"https://www.federalregister.gov/documents/2025/06/13/2025-10789/medical-devices-radiology-devices-classification-of-the-radiological-computer-assisted-detection-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-10789?publication_date=2025-06-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-13/2025-10789/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":813,"last_updated":"2026-04-16 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-13/pdf/2025-10789.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10789.pdf?1749732317","publication_date":"2025-06-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/13/2025-10789.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-1529","supporting_documents_count":0,"docket_id":"FDA-2025-N-1529","document_id":"FDA-2025-N-1529-0001","regulation_id_number":null,"title":"Medical Devices; Radiology Devices; Classification of the Radiological Computer Assisted Detection and Diagnosis Software","checked_regulationsdotgov_at":"2025-06-14T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24969,"subtype":null,"title":"Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software","toc_doc":"Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software","toc_subject":"Medical Devices","topics":["Medical devices","Radiation protection","X-rays"],"type":"Rule","volume":90}