Regulatory Policy Analyst

0910-AG74 201510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 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 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)) No NPRM 04/19/2013 78 FR 23508 NPRM Comment Period End 06/18/2013 Final Action 03/00/2016 Includes Retrospective Review under E.O. 13563 with small business burden reduction. No None No No No Yes Tozia Hazlett Regulatory Policy Analyst 0910 Food and Drug Administration FDA 301 796-6119 tozia.hazlett@fda.hhs.gov Center for Devices and Radiological Health, WO66, Room 5424, 10903 New Hampshire Avenue, Silver Spring MD 20993