{"abstract":"The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.","action":"Notice; 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/2026/02/06/2026-02377.html","cfr_references":[],"citation":"91 FR 5485","comment_url":null,"comments_close_on":"2026-04-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the notice by April 7, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-0232"],"dockets":[{"supporting_documents":[{"title":"Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff","document_id":"FDA-2026-N-0232-0002"}],"agency_name":"FDA","documents":[{"comment_count":14,"comment_start_date":"2026-02-06","updated_at":"2026-04-08T17:56:16.272-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-0232-0001","allow_late_comments":false,"id":"FDA-2026-N-0232-0001","comment_end_date":"2026-04-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2026-N-0232","title":"Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments"}],"document_number":"2026-02377","effective_on":null,"end_page":5489,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/02/06/2026-02377.xml","html_url":"https://www.federalregister.gov/documents/2026/02/06/2026-02377/medical-devices-exemptions-from-premarket-notification-class-ii-devices-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-02377?publication_date=2026-02-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-02-06/2026-02377/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":3457,"last_updated":"2026-07-27 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02377.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02377.pdf?1770299117","publication_date":"2026-02-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/02/06/2026-02377.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff","document_id":"FDA-2026-N-0232-0002"}],"comments_count":14,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-0232","supporting_documents_count":1,"docket_id":"FDA-2026-N-0232","document_id":"FDA-2026-N-0232-0001","regulation_id_number":null,"title":"Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments","checked_regulationsdotgov_at":"2026-04-09T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5485,"subtype":null,"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments","toc_doc":"Exemptions from Premarket Notification: Class II Devices","toc_subject":"Medical Devices","topics":[],"type":"Notice","volume":91}