{"abstract":"The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls) 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 ECP devices for other intended uses specified in this proposed order. 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 for other intended uses specified in this proposed order. 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/2013/05/21/2013-12122.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"78 FR 29672","comment_url":null,"comments_close_on":"2013-08-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed order by August 19, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market ECP devices for specified intended uses listed in section IX 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 for the proposed effective date of any final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0487"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":2,"comment_start_date":"2013-05-21","updated_at":"2023-03-01T13:10:51.626-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-N-0487-0001","allow_late_comments":null,"id":"FDA-2013-N-0487-0001","comment_end_date":"2013-08-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-N-0487","title":"Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina That Is Refractory to Optimal Antianginal Medical Therapy and Without Options for Revascularization; Effective Date of Requirement for Pr"}],"document_number":"2013-12122","effective_on":null,"end_page":29680,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/21/2013-12122.xml","html_url":"https://www.federalregister.gov/documents/2013/05/21/2013-12122/cardiovascular-devices-reclassification-of-external-counter-pulsating-devices-for-treatment-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-12122?publication_date=2013-05-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-21/2013-12122/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":543,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-21/pdf/2013-12122.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-12122.pdf?1369054166","publication_date":"2013-05-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/21/2013-12122.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0487","supporting_documents_count":0,"docket_id":"FDA-2013-N-0487","document_id":"FDA-2013-N-0487-0001","regulation_id_number":null,"title":"Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina That Is Refractory to Optimal Antianginal Medical Therapy and Without Options for Revascularization; Effective Date of Requirement for Pr","checked_regulationsdotgov_at":"2023-03-01T18:10:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":29672,"subtype":null,"title":"Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses","toc_doc":"Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina, etc.","toc_subject":"Cardiovascular Devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":78}