<?xml version="1.0" encoding="UTF-8"?><BillSummaries>
    <item congress="117" measure-type="hr" measure-number="8299" measure-id="id117hr8299" originChamber="HOUSE" orig-publish-date="2022-07-07" update-date="2022-11-21">
        <title>To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.</title>
        <summary summary-id="id117hr8299v00" currentChamber="HOUSE" update-date="2022-11-21">
            <action-date>2022-07-07</action-date>
            <action-desc>Introduced in House</action-desc>
            <summary-text><![CDATA[
     <p>This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.</p>
  ]]></summary-text>
        </summary>
    </item>
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        <dc:language>EN</dc:language>
        <dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
        <dc:contributor>Congressional Research Service, Library of Congress</dc:contributor>
        <dc:description>This file contains bill summaries for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.</dc:description>
    </dublinCore>
</BillSummaries>
