{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,\" which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.","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/2015/08/14/2015-20005.html","cfr_references":[],"citation":"80 FR 48868","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0967"],"dockets":[],"document_number":"2015-20005","effective_on":null,"end_page":48869,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/14/2015-20005.xml","html_url":"https://www.federalregister.gov/documents/2015/08/14/2015-20005/intent-to-exempt-certain-unclassified-class-ii-and-class-i-reserved-medical-devices-from-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-20005?publication_date=2015-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-14/2015-20005/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":740,"last_updated":"2026-09-22 18:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-14/pdf/2015-20005.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-20005.pdf?1439469951","publication_date":"2015-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/14/2015-20005.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":"2015-09-03T06:00:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48868,"subtype":null,"title":"Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}