{"abstract":"The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the adjunctive predictive cardiovascular indicator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.","action":"Final amendment; 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/2022/02/14/2022-03096.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"87 FR 8190","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 14, 2022. The classification was applicable on March 16, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0999"],"dockets":[],"document_number":"2022-03096","effective_on":"2022-02-14","end_page":8192,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/14/2022-03096.xml","html_url":"https://www.federalregister.gov/documents/2022/02/14/2022-03096/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-predictive-cardiovascular","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-03096?publication_date=2022-02-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-14/2022-03096/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":846,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-14/pdf/2022-03096.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-03096.pdf?1644587130","publication_date":"2022-02-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/14/2022-03096.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0999","supporting_documents_count":0,"docket_id":"FDA-2021-N-0999","document_id":"FDA-2021-N-0999-0001","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator","checked_regulationsdotgov_at":"2022-02-15T04:30:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8190,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator","toc_doc":"Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":87}