{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance \"Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.\" This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.","action":"Notice of availability.","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/2026/06/05/2026-11303.html","cfr_references":[],"citation":"91 FR 34240","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 5, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0967"],"dockets":[{"supporting_documents":[{"title":"Reference 1 - Convenience Kits Interim Regulatory Guidance FDA-2014-D-0967 re Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administr","document_id":"FDA-2014-D-0967-0032"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-05","updated_at":"2026-06-09T12:59:39.865-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-0967-0036","allow_late_comments":false,"id":"FDA-2014-D-0967-0036","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2014-D-0967","title":"Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements"}],"document_number":"2026-11303","effective_on":null,"end_page":34242,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/05/2026-11303.xml","html_url":"https://www.federalregister.gov/documents/2026/06/05/2026-11303/intent-to-exempt-certain-unclassified-medical-devices-from-premarket-notification-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11303?publication_date=2026-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-05/2026-11303/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":899,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-05/pdf/2026-11303.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11303.pdf?1780577113","publication_date":"2026-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/05/2026-11303.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 - Convenience Kits Interim Regulatory Guidance FDA-2014-D-0967 re Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administr","document_id":"FDA-2014-D-0967-0032"}],"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-2014-D-0967","supporting_documents_count":1,"docket_id":"FDA-2014-D-0967","document_id":"FDA-2014-D-0967-0036","regulation_id_number":null,"title":"Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements","checked_regulationsdotgov_at":"2026-06-09T16:59:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34240,"subtype":null,"title":"Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}