{"abstract":"The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations.","action":"Final rule; correcting amendments.","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/2015/02/27/2015-03943.html","cfr_references":[{"chapter":null,"citation_url":null,"part":803,"title":21}],"citation":"80 FR 10586","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 14, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0393"],"dockets":[],"document_number":"2015-03943","effective_on":"2015-08-14","end_page":10587,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/27/2015-03943.xml","html_url":"https://www.federalregister.gov/documents/2015/02/27/2015-03943/medical-device-reporting-electronic-submission-requirements-correcting-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-03943?publication_date=2015-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-27/2015-03943/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1404,"last_updated":"2026-04-04 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-27/pdf/2015-03943.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-03943.pdf?1424958861","publication_date":"2015-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/27/2015-03943.txt","regulation_id_number_info":{"0910-AF86":{"issue":"201310","html_url":"https://www.federalregister.gov/regulations/0910-AF86/medical-device-reporting-electronic-submission-requirements","title":"Medical Device Reporting; Electronic Submission Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AF86&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF86"],"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-2008-N-0393","supporting_documents_count":0,"docket_id":"FDA-2008-N-0393","regulation_id_number":null,"title":"Medical Device Reporting: Electronic Submission Requirements","checked_regulationsdotgov_at":"2015-03-19T06:00:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":10586,"subtype":null,"title":"Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments","toc_doc":"Electronic Submission Requirements; Correcting Amendments","toc_subject":"Medical Device Reporting:","topics":["Imports","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":80}