{"abstract":"As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seeking public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.","action":"Notification; request for comments.","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/2026/08/17/2026-16729.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"870","title":21},{"chapter":null,"citation_url":null,"part":"876","title":21},{"chapter":null,"citation_url":null,"part":"878","title":21}],"citation":"91 FR 53205","comment_url":"http://www.regulations.gov/commenton/FDA-2025-N-6224-0011","comments_close_on":"2026-10-16","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the notification must be submitted by October 16, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6224"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":2,"comment_start_date":"2026-08-17","updated_at":"2026-09-15T01:56:49.727-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6224-0011","allow_late_comments":false,"id":"FDA-2025-N-6224-0011","comment_end_date":"2026-10-17","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2025-N-6224","title":"Distinct Classification of Accessories in Class I (2025)"}],"document_number":"2026-16729","effective_on":null,"end_page":53209,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/17/2026-16729.xml","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16729/medical-devices-classification-of-accessories-distinct-from-other-devices-proposed-list-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16729?publication_date=2026-08-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-17/2026-16729/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":2743,"last_updated":"2026-09-20 18:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16729.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16729.pdf?1786711515","publication_date":"2026-08-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/17/2026-16729.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-6224","supporting_documents_count":0,"docket_id":"FDA-2025-N-6224","document_id":"FDA-2025-N-6224-0011","regulation_id_number":null,"title":"Distinct Classification of Accessories in Class I (2025)","checked_regulationsdotgov_at":"2026-09-16T08:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2025-N-6224-0011","significant":null,"signing_date":null,"start_page":53205,"subtype":null,"title":"Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments","toc_doc":"Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I","toc_subject":"Medical Devices","topics":[],"type":"Proposed Rule","volume":91}