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federal_register: 2016-13989

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-13989 Use of Symbols in Labeling Rule 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. 2016-06-15 2016 6 https://www.federalregister.gov/documents/2016/06/15/2016-13989/use-of-symbols-in-labeling https://www.govinfo.gov/content/pkg/FR-2016-06-15/pdf/2016-13989.pdf Health and Human Services Department; Food and Drug Administration 221,199 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,...

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