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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-AF86</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200610</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>Medical Device Reporting; Electronic Submission Requirements</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulations to require that reports submitted to the agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive.  FDA is taking this action to improve the agencys systems for collecting and analyzing postmarketing safety reports.  The proposed change would help the agency to more quickly review safety reports and identify emerging public health issues.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>First Time 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 803</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360i</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360j</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <RPLAN_INFO>
            <STMT_OF_NEED><![CDATA[The proposed rule would require user facilities and medical device manufacturers and importers to send medical device adverse event reports electronically instead of using a paper form.  FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports.]]></STMT_OF_NEED>
            <LEGAL_BASIS><![CDATA[The agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The proposed rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA electronically instead of using a hard copy form.]]></LEGAL_BASIS>
            <ALTERNATIVES><![CDATA[The alternatives to this rulemaking include not updating the medical device reporting requirements and not requiring electronic submission of this information. For over 20 years, medical device manufacturers, importers, and user facilities have sent adverse event reports to FDA on paper forms.  Processing paper forms is a time consuming and expensive process. FDA believes this rulemaking is the preferable alternative.]]></ALTERNATIVES>
            <COSTS_AND_BENEFITS><![CDATA[FDA estimates that over 80 percent of the adverse event reports it receives come directly from the reporter's computer databases.  Computer applications are available that would take the information from the corporate database and produce an electronic file that can be sent to the FDA.  Once reporters have developed the electronic reporting capability, they would save significant mailing and adminstrative processing costs.  FDA is developing an electronic system for reporters who do not have the capability to produce the required electronic file.]]></COSTS_AND_BENEFITS>
            <RISKS><![CDATA[None]]></RISKS>
        </RPLAN_INFO>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>03/00/2007</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Undetermined</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <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>
