{"abstract":"The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","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/2015/08/18/2015-20317.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"80 FR 49895","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective August 18, 2015. The classification was applicable on June 23, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2723"],"dockets":[],"document_number":"2015-20317","effective_on":"2015-08-18","end_page":49897,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/18/2015-20317.xml","html_url":"https://www.federalregister.gov/documents/2015/08/18/2015-20317/medical-devices-cardiovascular-devices-classification-of-the-esophageal-thermal-regulation-device","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-20317?publication_date=2015-08-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-18/2015-20317/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":302,"last_updated":"2026-07-27 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-18/pdf/2015-20317.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-20317.pdf?1439815571","publication_date":"2015-08-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/18/2015-20317.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-2723","supporting_documents_count":0,"docket_id":"FDA-2015-N-2723","regulation_id_number":null,"title":"Classification of the Esophageal Thermal Regulation Device","checked_regulationsdotgov_at":"2015-09-07T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49895,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device","toc_doc":"Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":80}