{"abstract":"The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.","action":"Final rule.","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/2013/09/24/2013-23059.html","cfr_references":[{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":801,"title":21},{"chapter":null,"citation_url":null,"part":803,"title":21},{"chapter":null,"citation_url":null,"part":806,"title":21},{"chapter":null,"citation_url":null,"part":810,"title":21},{"chapter":null,"citation_url":null,"part":814,"title":21},{"chapter":null,"citation_url":null,"part":820,"title":21},{"chapter":null,"citation_url":null,"part":821,"title":21},{"chapter":null,"citation_url":null,"part":822,"title":21},{"chapter":null,"citation_url":null,"part":830,"title":21}],"citation":"78 FR 58786","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 23, 2013, except Sec. Sec. 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective October 24, 2013. The incorporation by reference of Sec. 830.20 listed in the rule is approved by the Director of the Office of the Federal Register as of December 23, 2013. The incorporation by reference of Sec. Sec. 830.10 and 830.100 listed in the rule is approved by the Director of the Office of the Federal Register as of October 24, 2013. Certain provisions have later compliance dates as discussed in section VII. B. \"Compliance Dates.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0090"],"dockets":[],"document_number":"2013-23059","effective_on":"2013-12-23","end_page":58828,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/09/24/2013-23059.xml","html_url":"https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-23059?publication_date=2013-09-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-09-24/2013-23059/mods.xml","not_received_for_publication":null,"page_length":43,"page_views":{"count":323056,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-09-24/pdf/2013-23059.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-23059.pdf?1379681229","publication_date":"2013-09-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/09/24/2013-23059.txt","regulation_id_number_info":{"0910-AG31":{"issue":"201304","html_url":"https://www.federalregister.gov/regulations/0910-AG31/unique-device-identification","title":"Unique Device Identification","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201304&RIN=0910-AG31&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG31"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Alphatec Spine - Supplement","document_id":"FDA-2011-N-0090-0273"},{"title":"duplicate submission","document_id":"FDA-2011-N-0090-0220"},{"title":"duplicate submission","document_id":"FDA-2011-N-0090-0219"},{"title":"see docket 2011-n-0719","document_id":"FDA-2011-N-0090-0218"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG31/unique-device-identification","title":"Unique Device Identification"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0090","supporting_documents_count":4,"docket_id":"FDA-2011-N-0090","regulation_id_number":"0910-AG31","title":"Unique Device Identification System","checked_regulationsdotgov_at":"2013-10-14T06:00:12Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":58786,"subtype":null,"title":"Unique Device Identification System","toc_doc":"Unique Device Identification System","toc_subject":null,"topics":["Administrative practice and procedure","Confidential business information","Imports","Incorporation by reference","Labeling","Medical devices","Medical research","Reporting and recordkeeping requirements"],"type":"Rule","volume":78}