{"abstract":"The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Alto Development Corp. (the petitioner) reclassifying the 316L stainless steel suture for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations (CFR). Although FDA reclassified the device in 1986, it inadvertently neglected to publish a notice of the reclassification in the Federal Register or codify the change in the CFR.","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/2000/04/13/00-9129.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"65 FR 19835","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 15, 2000.","disposition_notes":null,"docket_ids":["Docket No. 86P-0087"],"dockets":[],"document_number":"00-9129","effective_on":"2000-05-15","end_page":19836,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/04/13/00-9129.xml","html_url":"https://www.federalregister.gov/documents/2000/04/13/00-9129/medical-devices-reclassification-and-codification-of-the-stainless-steel-suture","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-9129?publication_date=2000-04-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-04-13/00-9129/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":118,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-04-13/pdf/00-9129.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-04-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/04/13/00-9129.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T02:26:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19835,"subtype":null,"title":"Medical Devices; Reclassification and Codification of the Stainless Steel Suture","toc_doc":null,"toc_subject":null,"topics":["Medical devices"],"type":"Rule","volume":65}