federal_register: 2013-09175

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-09175 Use of Certain Symbols in Labeling Proposed Rule The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a "standardized symbol") and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labeling of prescription devices. 2013-04-19 2013 4 https://www.federalregister.gov/documents/2013/04/19/2013-09175/use-of-certain-symbols-in-labeling https://www.govinfo.gov/content/pkg/FR-2013-04-19/pdf/2013-09175.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been...

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