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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-AF76</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200604</PUBLICATION_ID>
            <PUBLICATION_TITLE>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>Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 809.  The purpose of this review is to determine if any of the regulations in part 809 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities.  FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 809; 2) the nature of complaints or comments received concerning a regulation in part 809; 3) the complexity of a regulation in part 809; 4) the extent to which a regulation in part 809 overlaps, duplicates, or conflicts with other Federal, State, or Government rules; and 5) the degree to which technology economic conditions or other factors have changed in the area affected by a regulation in part 809.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Prerule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <RFA_SECTION_610_REVIEW>Section 610 Review</RFA_SECTION_610_REVIEW>
        <CFR_LIST>
            <CFR>21 CFR 809.10</CFR>
            <CFR>21 CFR 809.30</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 351</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360j</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>Begin Review of Current Regulation</TTBL_ACTION>
                <TTBL_DATE>04/00/2006</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>End Review of Current Regulation</TTBL_ACTION>
                <TTBL_DATE>11/00/2007</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Madhusoodana</FIRST_NAME>
                <LAST_NAME>Nambiar</LAST_NAME>
                <TITLE>Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-5837</PHONE>
                <FAX>301 847-8145</FAX>
                <EMAIL>madhusoodana.nambiar@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Devices and Radiological Health, WO 66, Room 5518, 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>
