{"abstract":"The Food and Drug Administration (FDA) is reclassifying six cardiovascular preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations.","action":"Final rule.","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/2001/04/10/01-8829.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21},{"chapter":null,"citation_url":null,"part":886,"title":21}],"citation":"66 FR 18540","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 10, 2001.","disposition_notes":null,"docket_ids":["Docket No. 99N-0035"],"dockets":[],"document_number":"01-8829","effective_on":"2001-05-10","end_page":18542,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2001/04/10/01-8829.xml","html_url":"https://www.federalregister.gov/documents/2001/04/10/01-8829/medical-devices-reclassification-of-six-cardiovascular-preamendments-class-iii-devices-into-class-ii","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/01-8829?publication_date=2001-04-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2001-04-10/01-8829/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":383,"last_updated":"2026-07-26 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2001-04-10/pdf/01-8829.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2001-04-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2001/04/10/01-8829.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18540,"subtype":null,"title":"Medical Devices; Reclassification of Six Cardiovascular Preamendments Class III Devices into Class II","toc_doc":"Reclassification of six preamendments Class III devices into Class II","toc_subject":"Medical devices:","topics":["Medical devices","Ophthalmic goods and services"],"type":"Rule","volume":66}