{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive open loop fluid therapy recommender 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 adjunctive open loop fluid therapy recommender'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.","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/2024/09/05/2024-19736.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"89 FR 72317","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 5, 2024. The classification was applicable on November 13, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3947"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-09-05","updated_at":"2024-09-05T09:57:08.898-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3947-0001","allow_late_comments":false,"id":"FDA-2024-N-3947-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-3947","title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender"}],"document_number":"2024-19736","effective_on":"2024-09-05","end_page":72319,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/05/2024-19736.xml","html_url":"https://www.federalregister.gov/documents/2024/09/05/2024-19736/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-open-loop-fluid-therapy","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-19736?publication_date=2024-09-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-05/2024-19736/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":946,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-05/pdf/2024-19736.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-19736.pdf?1725453915","publication_date":"2024-09-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/05/2024-19736.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-2024-N-3947","supporting_documents_count":0,"docket_id":"FDA-2024-N-3947","document_id":"FDA-2024-N-3947-0001","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender","checked_regulationsdotgov_at":"2024-09-06T13:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72317,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender","toc_doc":"Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":89}