{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant 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 classification of the manual surgical instrument for appropriate patient selection for orthopedic implant. We are taking this action because we have determined that classifying the device into class II 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 in part by reducing regulatory burdens.","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/2026/04/16/2026-07367.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"888","title":21}],"citation":"91 FR 20350","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective April 16, 2026. The classification was applicable on May 28, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-2887"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-04-16T13:57:48.518-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-2887-0001","allow_late_comments":false,"id":"FDA-2026-N-2887-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-2887","title":"Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant"}],"document_number":"2026-07367","effective_on":"2026-04-16","end_page":20352,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/16/2026-07367.xml","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07367/medical-devices-orthopedic-devices-classification-of-the-manual-surgical-instrument-for-appropriate","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-07367?publication_date=2026-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-16/2026-07367/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":343,"last_updated":"2026-04-17 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07367.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07367.pdf?1776257113","publication_date":"2026-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/16/2026-07367.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-2026-N-2887","supporting_documents_count":0,"docket_id":"FDA-2026-N-2887","document_id":"FDA-2026-N-2887-0001","regulation_id_number":null,"title":"Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant","checked_regulationsdotgov_at":"2026-04-17T10:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20350,"subtype":null,"title":"Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant","toc_doc":"Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}