{"abstract":"The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.","action":"Proposed rule.","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/2026/03/18/2026-05320.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"892","title":21}],"citation":"91 FR 12951","comment_url":null,"comments_close_on":"2026-05-18","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by May 18, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-5996"],"dockets":[{"supporting_documents":[{"title":"Reference 17 - Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis: Radiology Devices; Classification of Blood Irradiators","document_id":"FDA-2025-N-5996-0035"},{"title":"Reference 16 - Effect of in vitro x-irradiation on lymphocyte and granulocyte function","document_id":"FDA-2025-N-5996-0034"},{"title":"Reference 15b - Radiobiology for the Radiologist Chapter 10 - Radiation Carcinogenesis","document_id":"FDA-2025-N-5996-0033"},{"title":"Reference 15a - Radiobiology for the Radiologist Chapter 2 - Molecular Mechanisms of DNA and Chromosome Damage and Repair","document_id":"FDA-2025-N-5996-0032"},{"title":"Reference 13 - Reduction of EpCAM-Positive cells from a cell salvage product is achieved by leucocyte depletion filters alone","document_id":"FDA-2025-N-5996-0030"},{"title":"Reference 12 - X‐ray irradiation effectively inactivated lymphocytes in transfusion in vivo monitored by the bioluminescence transfusion-associated graft-versus-host disease model","document_id":"FDA-2025-N-5996-0029"},{"title":"Reference 9 - Transfusion-associated graft-versus-host disease transfusion-associated hyperkalemia, and potassium filtration: advancing safety and sufficiency of the blood supply","document_id":"FDA-2025-N-5996-0026"},{"title":"Reference 8 - Amotosalen UVA treatment inactivates T cells more effectively than the recommended gamma dose for prevention of transfusion-associated graft-versus-host disease","document_id":"FDA-2025-N-5996-0025"},{"title":"Reference 7 - Influence of Irradiation on Leukodepleted Small Unit Red Blood Cell Bags","document_id":"FDA-2025-N-5996-0024"},{"title":"Reference 6 - Serial assessment of biochemical changes in irradiated red blood cells","document_id":"FDA-2025-N-5996-0023"}],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2026-03-18","updated_at":"2026-05-19T01:56:22.177-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-5996-0001","allow_late_comments":false,"id":"FDA-2025-N-5996-0001","comment_end_date":"2026-05-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":34,"id":"FDA-2025-N-5996","title":"Medical Devices; Radiology Devices; Classification of Blood Irradiators"}],"document_number":"2026-05320","effective_on":null,"end_page":12966,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/18/2026-05320.xml","html_url":"https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-05320?publication_date=2026-03-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-18/2026-05320/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":1776,"last_updated":"2026-06-15 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05320.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05320.pdf?1773751519","publication_date":"2026-03-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/18/2026-05320.txt","regulation_id_number_info":{"0910-AI93":{"issue":"202504","html_url":"https://www.federalregister.gov/regulations/0910-AI93/radiology-devices-classification-of-blood-irradiator-devices","title":"Radiology Devices; 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