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HHS/FDA RIN: 0910-AG74 Publication ID: Fall 2015 
Title: Use of Symbols in Labeling 

The purpose of this rule is to allow for the inclusion in device labeling of stand-alone symbols established as part of a standard developed by a national or international standards development organization, provided that such symbols are explained in a symbols glossary that is included in the labeling for the medical device. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labeling of prescription devices.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 660.2    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 809.3    21 CFR 809.10   
Legal Authority: Sec. 502(c) of the Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 352(c)    701(a) of the FD&C Act (21 U.S.C. 371(a))   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/19/2013  78 FR 23508   
NPRM Comment Period End  06/18/2013 
Final Action  03/00/2016 
Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
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: No 
Agency Contact:
Tozia Hazlett
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO66, Room 5424, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6119