{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long- term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.","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/2016/02/12/2016-02876.html","cfr_references":[{"chapter":null,"citation_url":null,"part":868,"title":21},{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"81 FR 7446","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 12, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-1174"],"dockets":[],"document_number":"2016-02876","effective_on":"2016-02-12","end_page":7452,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/02/12/2016-02876.xml","html_url":"https://www.federalregister.gov/documents/2016/02/12/2016-02876/anesthesiology-devices-reclassification-of-membrane-lung-for-long-term-pulmonary-support","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-02876?publication_date=2016-02-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-02-12/2016-02876/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":4079,"last_updated":"2026-10-25 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-02-12/pdf/2016-02876.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-02876.pdf?1455198377","publication_date":"2016-02-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/02/12/2016-02876.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2A, FDA Executive Summary Circulatory System Devices Panel May 7, 2014 re Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respirator","document_id":"FDA-2012-N-1174-0009"},{"title":"Reference 2, Circualtory System Devices Panel Meeting Transcript May 7, 2014 re Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Ca","document_id":"FDA-2012-N-1174-0008"},{"title":"Reference 1A, FDA Executive Summary Circulatory System Devices Panel Sept. 12, 2013 re Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respira","document_id":"FDA-2012-N-1174-0007"},{"title":"Reference 1, Circulatory System Devices Panel Meeting Transcript September 12, 2013 re Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respira","document_id":"FDA-2012-N-1174-0006"},{"title":"Reference List re Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure","document_id":"FDA-2012-N-1174-0005"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-1174","supporting_documents_count":5,"docket_id":"FDA-2012-N-1174","regulation_id_number":null,"title":"Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support","checked_regulationsdotgov_at":"2016-03-03T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7446,"subtype":null,"title":"Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure","toc_doc":"Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure","toc_subject":"Anesthesiology Devices:","topics":["Medical devices"],"type":"Rule","volume":81}