{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions 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 classification of the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. 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.","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/2023/11/09/2023-24717.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"864","title":21}],"citation":"88 FR 77198","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective November 9, 2023. The classification was applicable on September 15, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-4487"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-11-09","updated_at":"2023-11-09T09:32:09.631-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-4487-0001","allow_late_comments":null,"id":"FDA-2023-N-4487-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-4487","title":"Medical Devices; Hematology and Pathology Devices; Classification of the Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions"}],"document_number":"2023-24717","effective_on":"2023-11-09","end_page":77200,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/09/2023-24717.xml","html_url":"https://www.federalregister.gov/documents/2023/11/09/2023-24717/medical-devices-hematology-and-pathology-devices-classification-of-the-container-system-for-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-24717?publication_date=2023-11-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-09/2023-24717/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2174,"last_updated":"2026-08-24 02:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-09/pdf/2023-24717.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-24717.pdf?1699451151","publication_date":"2023-11-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/09/2023-24717.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-2023-N-4487","supporting_documents_count":0,"docket_id":"FDA-2023-N-4487","document_id":"FDA-2023-N-4487-0001","regulation_id_number":null,"title":"Medical Devices; Hematology and Pathology Devices; Classification of the Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions","checked_regulationsdotgov_at":"2023-11-10T14:55:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":77198,"subtype":null,"title":"Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions","toc_doc":"Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions","toc_subject":"Medical Devices:\n","topics":["Blood","Medical devices","Packaging and containers"],"type":"Rule","volume":88}