<?xml version="1.0" encoding="UTF-8"?><BillSummaries>
<item congress="115" measure-type="s" measure-number="1069" measure-id="id115s1069" originChamber="SENATE" orig-publish-date="2017-05-08" update-date="2018-01-17">
<title>Medical Device Safety Monitoring Act</title>
<summary summary-id="id115s1069v00" currentChamber="SENATE" update-date="2018-01-17">
<action-date>2017-05-08</action-date>
<action-desc>Introduced in Senate</action-desc>
<summary-text><![CDATA[<p><b>Medical Device Safety Monitoring Act</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to support pilot projects in order to provide timely and reliable information on the safety and effectiveness of marketed medical devices. The projects must: (1) be designed to generate safety and active surveillance data, (2) inform support for safety and active surveillance activities, (3) be coordinated with a system for evaluating medical device technology that operates under a board with representation from consumer groups and device manufacturers, and (4) use electronic health data.</p> <p>The FDA may determine that a manufacturer's participation in a pilot project satisfies requirements regarding reporting or postmarket surveillance if the project captures adverse event information and the FDA has established procedures to publish safety information from the project.</p> <p>Not later than January 31, 2021, the FDA must evaluate real world evidence pilot projects, such as the ones supported by this bill, for their ability to inform decision-making and efficiently generate evidence about the safety or effectiveness of medical devices.</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>
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</BillSummaries>
