{"abstract":"The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device 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 interventional cardiovascular implant simulation software device'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/2022/12/28/2022-28173.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"87 FR 79801","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 28, 2022. The classification was applicable on September 8, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-3185"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-12-28","updated_at":"2023-02-27T18:07:36.864-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-3185-0001","allow_late_comments":null,"id":"FDA-2022-N-3185-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-3185","title":"Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device"}],"document_number":"2022-28173","effective_on":"2022-12-28","end_page":79803,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/12/28/2022-28173.xml","html_url":"https://www.federalregister.gov/documents/2022/12/28/2022-28173/medical-devices-cardiovascular-devices-classification-of-the-interventional-cardiovascular-implant","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-28173?publication_date=2022-12-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-12-28/2022-28173/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2079,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-28/pdf/2022-28173.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-28173.pdf?1672148719","publication_date":"2022-12-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/12/28/2022-28173.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-2022-N-3185","supporting_documents_count":0,"docket_id":"FDA-2022-N-3185","document_id":"FDA-2022-N-3185-0001","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device","checked_regulationsdotgov_at":"2023-02-27T23:07:35Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":79801,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device","toc_doc":"Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":87}