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HHS/FDA RIN: 0910-AG74 Publication ID: 2012 
Title: Use of Symbols in Labeling 
Abstract: The purpose of this proposed rule is to implement section 502(c) of the FD&C Act and to revise 21 CFR 801.15 (prominence of required label statements) using the authority under section 514(c) of the FD&C Act to allow for the inclusion of certain standardized symbols recognized by FDA for use on the labeling of medical devices. If this proposed rule is finalized, certain symbols in compliance with International Standards Organization (ISO) Standard 15223 may be used in medical device labeling with explanatory text or symbols glossary with accompanying labeling, as may other standardized symbols in the future when adopted by a national or international standards development organization and if recognized by FDA guidance or other regulatory action. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 660.28; 21 CFR 660.35; 21 CFR 660.45; 21 CFR 660.55; 21 CFR 801.15(c)(1); 21 CFR 801.109; 21 CFR 809.10; ... (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C Act), 21 USC 352(c); sec 514(c) of FD&C Act, 21 USC 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA) 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2013   
Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211.  Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Mary Follette Story
Human Factors and Accessible Medical Technology Specialist
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, Room 2553, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-1456
Email: molly.story@fda.hhs.gov

 
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