{"abstract":"The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify nonroller-type cardiopulmonary bypass blood pump devices, when used for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls) and subject to premarket notification based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for nonroller-type cardiopulmonary bypass blood pump devices for temporary ventricular support. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements when used for temporary ventricular support. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.","action":"Proposed 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/2014/01/07/2014-00027.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"79 FR 765","comment_url":null,"comments_close_on":"2014-04-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed order by April 7, 2014. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market nonroller-type cardiopulmonary bypass blood pump devices for temporary ventricular support will need to file a PMA or a notice of completion of a PDP within 90 days of the effective date of the final order. See section XVII of this document for the proposed effective date of any final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1518"],"dockets":[],"document_number":"2014-00027","effective_on":null,"end_page":773,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/01/07/2014-00027.xml","html_url":"https://www.federalregister.gov/documents/2014/01/07/2014-00027/cardiovascular-devices-reclassification-of-nonroller-type-cardiopulmonary-bypass-blood-pumps-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-00027?publication_date=2014-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-01-07/2014-00027/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":639,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/2014-00027.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-00027.pdf?1389016390","publication_date":"2014-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/01/07/2014-00027.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-02-19T05:12:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":765,"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":"Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; etc.","toc_subject":"Cardiovascular Devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":79}