{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.","action":"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/2015/06/08/2015-13889.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"80 FR 32307","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 8, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1518"],"dockets":[],"document_number":"2015-13889","effective_on":"2015-06-08","end_page":32311,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/08/2015-13889.xml","html_url":"https://www.federalregister.gov/documents/2015/06/08/2015-13889/cardiovascular-devices-reclassification-of-nonroller-type-cardiopulmonary-bypass-blood-pumps-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-13889?publication_date=2015-06-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-08/2015-13889/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":999,"last_updated":"2026-07-27 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-08/pdf/2015-13889.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-13889.pdf?1433508362","publication_date":"2015-06-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/08/2015-13889.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference -2  Transcript of the December 6, 2012 meeting of the Circulatory System Devices Panel re Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of","document_id":"FDA-2013-N-1518-0005"},{"title":"Reference -1 FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting, December 5-6, 2012 re Cardiovascular Devices; Reclassification of Nonroller-Type\nCardiopulmonary Bypass Blood Pumps for Cardiopulmonary and\nCirculatory By","document_id":"FDA-2013-N-1518-0004"},{"title":"REFERENCE LIST re Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and\nCirculatory Bypass; Effective Date of Requirement for Premarket Approval\nfor Nonroller-Type Cardiopulmonary Bypass Bloo","document_id":"FDA-2013-N-1518-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-1518","supporting_documents_count":3,"docket_id":"FDA-2013-N-1518","regulation_id_number":null,"title":"Cardiovascular Devices; Reclassification of Nonroller-type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-type Cardiopulmonary Bypass Blood Pumps for Tempor","checked_regulationsdotgov_at":"2015-06-28T06:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32307,"subtype":null,"title":"Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support","toc_doc":"Cardiovascular Devices; Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Reclassification; etc.","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":80}