{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.\" This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions.","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/2016/11/08/2016-26933.html","cfr_references":[],"citation":"81 FR 78603","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-2013-D-0743"],"dockets":[],"document_number":"2016-26933","effective_on":null,"end_page":78605,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/08/2016-26933.xml","html_url":"https://www.federalregister.gov/documents/2016/11/08/2016-26933/medical-device-reporting-for-manufacturers-guidance-for-industry-and-food-and-drug-administration","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-26933?publication_date=2016-11-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-08/2016-26933/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":817,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-08/pdf/2016-26933.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-26933.pdf?1478526353","publication_date":"2016-11-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/08/2016-26933.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0743","supporting_documents_count":0,"docket_id":"FDA-2013-D-0743","regulation_id_number":null,"title":"Medical Device Reporting for Manufacturers Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2016-11-28T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78603,"subtype":null,"title":"Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Medical Device Reporting for Manufacturers","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}