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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-09-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG74</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201210</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Use of Symbols in Labeling</RULE_TITLE>
        <ABSTRACT><![CDATA[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.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 660.28</CFR>
            <CFR>21 CFR 660.35</CFR>
            <CFR>21 CFR 660.45</CFR>
            <CFR>21 CFR 660.55</CFR>
            <CFR>21 CFR 801.15(c)(1)</CFR>
            <CFR>21 CFR 801.109</CFR>
            <CFR>21 CFR 809.10</CFR>
            <CFR>...</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>sec 502(c) of the Food Drug and Cosmetic Act (FD&amp;C Act), 21 USC 352(c)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 514(c) of FD&amp;C Act, 21 USC 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>04/00/2013</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Includes Retrospective Review under E.O. 13563 with small business burden reduction.</ADDITIONAL_INFO>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>Yes</ENERGY_AFFECTED>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Mary</FIRST_NAME>
                <LAST_NAME>Story</LAST_NAME>
                <MIDDLE_NAME>Follette</MIDDLE_NAME>
                <TITLE>Human Factors and Accessible Medical Technology Specialist</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-1456</PHONE>
                <EMAIL>molly.story@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Devices and Radiological Health, Room 2553, 10903 New Hampshire Avenue,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
