{"abstract":"The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator 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 adjunctive cardiovascular status indicator'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/2017/07/28/2017-15901.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"82 FR 35065","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective July 28, 2017. The classification was applicable on December 21, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-1620"],"dockets":[],"document_number":"2017-15901","effective_on":"2017-07-28","end_page":35067,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/07/28/2017-15901.xml","html_url":"https://www.federalregister.gov/documents/2017/07/28/2017-15901/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-cardiovascular-status","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-15901?publication_date=2017-07-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-07-28/2017-15901/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":298,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-07-28/pdf/2017-15901.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-15901.pdf?1501159545","publication_date":"2017-07-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/07/28/2017-15901.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-2017-N-1620","supporting_documents_count":0,"docket_id":"FDA-2017-N-1620","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator","checked_regulationsdotgov_at":"2017-08-17T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35065,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator","toc_doc":"Cardiovascular Devices; Classification of Adjunctive Cardiovascular Status Indicator","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":82}