{"abstract":"The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.","action":"Proposed rule; amendment.","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/2012/11/19/2012-28015.html","cfr_references":[{"chapter":null,"citation_url":null,"part":801,"title":21}],"citation":"77 FR 69393","comment_url":null,"comments_close_on":"2012-12-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the amendment to the Proposed Rule by December 19, 2012. See section VII for the proposed effective dates of a final rule based on the amended proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0090"],"dockets":[],"document_number":"2012-28015","effective_on":null,"end_page":69399,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/11/19/2012-28015.xml","html_url":"https://www.federalregister.gov/documents/2012/11/19/2012-28015/unique-device-identification-system","images":{"EP19NO12.001":{"large":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_large.png","medium":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_medium.png","original_size":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_original_size.png"}},"images_metadata":{"EP19NO12.001":{"large":{"identifier":"EP19NO12.001","content_type":"image/png","size":74131,"width":823,"sha":"ed6787b047250fc7e962cac9ff99a6fa","url":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_large.png","height":975},"medium":{"identifier":"EP19NO12.001","content_type":"image/png","size":34541,"width":496,"sha":"6e3c6559ea0aabcd05340fe56df509e4","url":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_medium.png","height":588},"original_size":{"identifier":"EP19NO12.001","content_type":"image/png","size":145561,"width":3745,"sha":"5f9a1613792c58ab6bb4f4f3fa7ecd71","url":"https://img.federalregister.gov/EP19NO12.001/EP19NO12.001_original_size.png","height":4436}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-28015?publication_date=2012-11-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-11-19/2012-28015/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":13278,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-11-19/pdf/2012-28015.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-28015.pdf?1353101364","publication_date":"2012-11-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/11/19/2012-28015.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":"2012-12-21T05:00:14Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":69393,"subtype":null,"title":"Unique Device Identification System","toc_doc":"Unique Device Identification System; Amendment","toc_subject":null,"topics":["Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":77}