{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.\" This draft guidance describes FDA's intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2014/08/01/2014-18198.html","cfr_references":[],"citation":"79 FR 44804","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0967"],"dockets":[],"document_number":"2014-18198","effective_on":null,"end_page":44805,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/01/2014-18198.xml","html_url":"https://www.federalregister.gov/documents/2014/08/01/2014-18198/intent-to-exempt-certain-class-ii-and-class-i-reserved-medical-devices-from-premarket-notification","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-18198?publication_date=2014-08-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-01/2014-18198/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":695,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-01/pdf/2014-18198.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-18198.pdf?1406811084","publication_date":"2014-08-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/01/2014-18198.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_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","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":"2014-10-01T05:00:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44804,"subtype":null,"title":"Intent To Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Exemption of Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}