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HHS/FDA

RIN: 0910-AG74

Publication ID: Fall 2015

Title: Use of Symbols in Labeling
Abstract: 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

Timetable:

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 Email: tozia.hazlett@fda.hhs.gov