{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as \"stand-alone symbols\") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement \"Rx only\" or \"[rx] only\" in the labeling for prescription devices.","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/2016/06/15/2016-13989.html","cfr_references":[{"chapter":null,"citation_url":null,"part":660,"title":21},{"chapter":null,"citation_url":null,"part":801,"title":21},{"chapter":null,"citation_url":null,"part":809,"title":21}],"citation":"81 FR 38911","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 13, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0125"],"dockets":[],"document_number":"2016-13989","effective_on":"2016-09-13","end_page":38931,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/15/2016-13989.xml","html_url":"https://www.federalregister.gov/documents/2016/06/15/2016-13989/use-of-symbols-in-labeling","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-13989?publication_date=2016-06-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-15/2016-13989/mods.xml","not_received_for_publication":null,"page_length":21,"page_views":{"count":131431,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-15/pdf/2016-13989.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-13989.pdf?1465908346","publication_date":"2016-06-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/15/2016-13989.txt","regulation_id_number_info":{"0910-AG74":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AG74/use-of-symbols-in-labeling","title":"Use of Symbols in Labeling","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG74&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG74"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 6 Final Regulatory Impact Analysis re Use of Certain Symbols in Labeling","document_id":"FDA-2013-N-0125-0023"},{"title":"06 Reference 5 Alternative to Prescription Device Labeling Guidance re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0022"},{"title":"Reference 4 IVD Symbols Guidance re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0021"},{"title":"Reference 3 Circular A119 re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0020"},{"title":"Reference 2 National Technology Transfer  Act re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0019"},{"title":"Reference 1 Frequently Asked Questions Guidance re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0018"},{"title":"Index List of References re Use of Symbols in Labeling","document_id":"FDA-2013-N-0125-0017"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG51/effective-date-of-requirement-for-premarket-approval-for-four-class-iii-preamendments-devices","title":"Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0125","supporting_documents_count":7,"docket_id":"FDA-2013-N-0125","regulation_id_number":"0910-AG51","title":"Use of Certain Symbols in Labeling","checked_regulationsdotgov_at":"2016-07-05T06:03:15Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":38911,"subtype":null,"title":"Use of Symbols in Labeling","toc_doc":"Use of Symbols in Labeling","toc_subject":null,"topics":["Biologics","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}