United States Government Publishing Office
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United States
National Archives and Records Administration
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government publication
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FR
Regulatory Information
2013_register
executive
2013-04-19
article
Use of Certain Symbols in Labeling
Proposed Rules
D09002ee1bdca57e7
D09002ee1bdca587c
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
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.
78 FR 23508
https://www.govinfo.gov/app/details/FR-2013-04-19/2013-09175
2013-09175
fr19ap13-21
RIN 0910-AG74
4160-01-P
Docket No. FDA-2013-N-0125
https://www.govinfo.gov/app/details/FR-2013-04-19/2013-09175
https://www.govinfo.gov/content/pkg/FR-2013-04-19/html/2013-09175.htm
https://www.govinfo.gov/content/pkg/FR-2013-04-19/pdf/2013-09175.pdf
Biologics
Labeling
Reporting and Recordkeeping Requirements
Medical Devices
8 p.
23508
23515
78 FR 23508
Code of Federal Regulations
Title 21 Part 660
21 CFR Part 660
Code of Federal Regulations
Title 21 Part 801
21 CFR Part 801
Code of Federal Regulations
Title 21 Part 809
21 CFR Part 809
Regulation Identification Number 0910-AG74
RIN 0910-AG74
Use of Certain Symbols in Labeling; Federal Register Vol. 78, Issue
PRORULE
2013-09175
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-06-18
Docket No. FDA-2013-N-0125
4160-01-P
2013-09175
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.
Submit electronic or written comments on the proposed rule by June 18, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 20, 2013, (see section VII). See section IX for the proposed effective date of a final rule based on the proposed rule in this document.
Michael Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796- 6283; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.
Biologics
Labeling
Reporting and Recordkeeping Requirements
Medical Devices
Use of Certain Symbols in Labeling
,
oira_submission@omb.eop.gov
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm075064.pdf
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077322.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072747.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 76
Office of the Federal Register, National Archives and Records Administration
2013-04-19
continuing
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224 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-04-19
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0042-1219
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https://www.govinfo.gov/app/details/FR-2013-04-19
https://www.govinfo.gov/content/pkg/FR-2013-04-19/pdf/FR-2013-04-19.pdf
https://www.govinfo.gov/content/pkg/FR-2013-04-19/xml/FR-2013-04-19.xml
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