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HHS/FDA

RIN: 0910-AG74

Publication ID: Fall 2014

Title: Use of Certain Symbols in Labeling
Abstract: The purpose of this rule is to allow for the inclusion in device labeling of certain stand-alone symbols contained in a standard that FDA recognizes, 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 ... (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	04/19/2013	78 FR 23508
NPRM Comment Period End	06/18/2013
Final Action	12/00/2014

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
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: No
Agency Contact: Mary W. Brady Senior Policy Analyst Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO66, Room 5426, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6089 Email: mary.brady@fda.hhs.gov