<?xml version="1.0" encoding="utf-8" standalone="no"?>
<measures>
  <measure>
    <type>Main</type>
    <parent-measure></parent-measure>
    <title>Percent of death Medical Device Reports (MDRs) reviewed within 5 business days during the month</title>
    <dictionary>OSB strives to review medical device adverse events resulting in death within 5 business days of receiving the submission. Timely review of death MDRs can minimize widespread failure of the device, thereby limiting the loss of life due to similar events as the one submitted.</dictionary>
    <dictionary>&lt;i&gt;Information is current as of December 31, 2012&lt;/i&gt;</dictionary>
    <footnotes>
      <note></note>
    </footnotes>
    <measure-description>Percent</measure-description>
    <chart-type>line</chart-type>
    <fiscal-year>
      <title>2011</title>
      <chart-min>0</chart-min>
      <chart-max>100</chart-max>
      <target-header>Target</target-header>
      <target-description></target-description>
      <summary>FY 2011 Overall: 99%</summary>
      <time>
        <frame>Oct 2010</frame>
        <target>90</target>
        <value>97</value>
      </time>
      <time>
        <frame>Nov 2010</frame>
        <target>90</target>
        <value>97</value>
      </time>
      <time>
        <frame>Dec 2010</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Jan 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Feb 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Mar 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Apr 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>May 2011</frame>
        <target>90</target>
        <value>100</value>
      </time>
      <time>
        <frame>Jun 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Jul 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Aug 2011</frame>
        <target>90</target>
        <value>100</value>
      </time>
      <time>
        <frame>Sep 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
    </fiscal-year>
    <fiscal-year>
      <chart-min>0</chart-min>
      <chart-max>100</chart-max>
      <title>2012</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2012 Overall: 97%</summary>
      <time>
        <frame>Oct 2011</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Nov 2011</frame>
        <target>90</target>
        <value>98</value>
      </time>
      <time>
        <frame>Dec 2011</frame>
        <target>90</target>
        <value>92</value>
      </time>
      <time>
        <frame>Jan 2012</frame>
        <target>90</target>
        <value>95</value>
      </time>
      <time>
        <frame>Feb 2012</frame>
        <target>90</target>
        <value>96</value>
      </time>
      <time>
        <frame>Mar 2012</frame>
        <target>90</target>
        <value>90</value>
      </time>
      <time>
        <frame>Apr 2012</frame>
        <target>90</target>
        <value>93</value>
      </time>
      <time>
        <frame>May 2012</frame>
        <target>90</target>
        <value>92</value>
      </time>
      <time>
        <frame>Jun 2012</frame>
        <target>90</target>
        <value>99</value>
      </time>
      <time>
        <frame>Jul 2012</frame>
        <target>90</target>
        <value>96</value>
      </time>
      <time>
        <frame>Aug 2012</frame>
        <target>90</target>
        <value>97</value>
      </time>
      <time>
        <frame>Sep 2012</frame>
        <target>90</target>
        <value>100</value>
      </time>
    </fiscal-year>
<fiscal-year>
      <chart-min>0</chart-min>
      <chart-max>100</chart-max>
      <title>2013</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2013 YTD: 95%</summary>
      <time>
        <frame>Oct 2012</frame>
        <target></target>
        <value>94</value>
      </time>
      <time>
        <frame>Nov 2012</frame>
        <target></target>
        <value>98</value>
      </time>
      <time>
        <frame>Dec 2012</frame>
        <target></target>
        <value>93</value>
      </time>
      <time>
        <frame>Jan 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Feb 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Mar 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Apr 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>May 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jun 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jul 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Aug 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Sep 2013</frame>
        <target></target>
        <value></value>
      </time>
    </fiscal-year>
  </measure>
  <measure>
    <type>Sub</type>
    <parent-measure>Percent of death Medical Device Reports (MDRs) reviewed within 5 business days during the month</parent-measure>
    <title>Number of death MDRs reviewed within 5 business days during the month</title>
    <dictionary></dictionary>
    <footnotes>
      <note></note>
    </footnotes>
    <measure-description>Number</measure-description>
    <chart-type>column</chart-type>
    <fiscal-year>
      <title>2011</title>
      <chart-min>0</chart-min>
      <chart-max>3000</chart-max>
      <target-header>Target</target-header>
      <target-description></target-description>
      <summary>FY 2011 Total: 9,275</summary>
      <time>
        <frame>Oct 2010</frame>
        <target></target>
        <value>411</value>
      </time>
      <time>
        <frame>Nov 2010</frame>
        <target></target>
        <value>445</value>
      </time>
      <time>
        <frame>Dec 2010</frame>
        <target></target>
        <value>629</value>
      </time>
      <time>
        <frame>Jan 2011</frame>
        <target></target>
        <value>515</value>
      </time>
      <time>
        <frame>Feb 2011</frame>
        <target></target>
        <value>687</value>
      </time>
      <time>
        <frame>Mar 2011</frame>
        <target></target>
        <value>2,177</value>
      </time>
      <time>
        <frame>Apr 2011</frame>
        <target></target>
        <value>942</value>
      </time>
      <time>
        <frame>May 2011</frame>
        <target></target>
        <value>935</value>
      </time>
      <time>
        <frame>Jun 2011</frame>
        <target></target>
        <value>622</value>
      </time>
      <time>
        <frame>Jul 2011</frame>
        <target></target>
        <value>535</value>
      </time>
      <time>
        <frame>Aug 2011</frame>
        <target></target>
        <value>697</value>
      </time>
      <time>
        <frame>Sep 2011</frame>
        <target></target>
        <value>680</value>
      </time>
    </fiscal-year>
    <fiscal-year>
      <chart-min>0</chart-min>
      <chart-max>3000</chart-max>
      <title>2012</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2012 Total: 8,757</summary>
      <time>
        <frame>Oct 2011</frame>
        <target></target>
        <value>585</value>
      </time>
      <time>
        <frame>Nov 2011</frame>
        <target></target>
        <value>506</value>
      </time>
      <time>
        <frame>Dec 2011</frame>
        <target></target>
        <value>545</value>
      </time>
      <time>
        <frame>Jan 2012</frame>
        <target></target>
        <value>578</value>
      </time>
      <time>
        <frame>Feb 2012</frame>
        <target></target>
        <value>592</value>
      </time>
      <time>
        <frame>Mar 2012</frame>
        <target></target>
        <value>617</value>
      </time>
      <time>
        <frame>Apr 2012</frame>
        <target></target>
        <value>484</value>
      </time>
      <time>
        <frame>May 2012</frame>
        <target></target>
        <value>448</value>
      </time>
      <time>
        <frame>Jun 2012</frame>
        <target></target>
        <value>580</value>
      </time>
      <time>
        <frame>Jul 2012</frame>
        <target></target>
        <value>565</value>
      </time>
      <time>
        <frame>Aug 2012</frame>
        <target></target>
        <value>526</value>
      </time>
      <time>
        <frame>Sep 2012</frame>
        <target></target>
        <value>2,731</value>
      </time>
    </fiscal-year>
<fiscal-year>
      <chart-min></chart-min>
      <chart-max></chart-max>
      <title>2013</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2013 YTD: 1,298</summary>
      <time>
        <frame>Oct 2012</frame>
        <target></target>
        <value>510</value>
      </time>
      <time>
        <frame>Nov 2012</frame>
        <target></target>
        <value>375</value>
      </time>
      <time>
        <frame>Dec 2012</frame>
        <target></target>
        <value>413</value>
      </time>
      <time>
        <frame>Jan 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Feb 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Mar 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Apr 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>May 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jun 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jul 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Aug 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Sep 2013</frame>
        <target></target>
        <value></value>
      </time>
    </fiscal-year>
  </measure>
  <measure>
    <type>Sub</type>
    <parent-measure>Percent of death Medical Device Reports (MDRs) reviewed within 5 business days during the month</parent-measure>
    <title>Total number of death MDRs reviewed during the month</title>
    <dictionary></dictionary>
    <footnotes>
      <note></note>
    </footnotes>
    <measure-description>Number</measure-description>
    <chart-type>column</chart-type>
    <fiscal-year>
      <title>2011</title>
      <chart-min>0</chart-min>
      <chart-max>3000</chart-max>
      <target-header>Target</target-header>
      <target-description></target-description>
      <summary>FY 2011 Total: 9,368</summary>
      <time>
        <frame>Oct 2010</frame>
        <target></target>
        <value>423</value>
      </time>
      <time>
        <frame>Nov 2010</frame>
        <target></target>
        <value>458</value>
      </time>
      <time>
        <frame>Dec 2010</frame>
        <target></target>
        <value>637</value>
      </time>
      <time>
        <frame>Jan 2011</frame>
        <target></target>
        <value>521</value>
      </time>
      <time>
        <frame>Feb 2011</frame>
        <target></target>
        <value>691</value>
      </time>
      <time>
        <frame>Mar 2011</frame>
        <target></target>
        <value>2,200</value>
      </time>
      <time>
        <frame>Apr 2011</frame>
        <target></target>
        <value>950</value>
      </time>
      <time>
        <frame>May 2011</frame>
        <target></target>
        <value>936</value>
      </time>
      <time>
        <frame>Jun 2011</frame>
        <target></target>
        <value>626</value>
      </time>
      <time>
        <frame>Jul 2011</frame>
        <target></target>
        <value>543</value>
      </time>
      <time>
        <frame>Aug 2011</frame>
        <target></target>
        <value>698</value>
      </time>
      <time>
        <frame>Sep 2011</frame>
        <target></target>
        <value>685</value>
      </time>
    </fiscal-year>
    <fiscal-year>
      <chart-min>0</chart-min>
      <chart-max>3000</chart-max>
      <title>2012</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2012 Total: 9,055</summary>
      <time>
        <frame>Oct 2011</frame>
        <target></target>
        <value>588</value>
      </time>
      <time>
        <frame>Nov 2011</frame>
        <target></target>
        <value>514</value>
      </time>
      <time>
        <frame>Dec 2011</frame>
        <target></target>
        <value>590</value>
      </time>
      <time>
        <frame>Jan 2012</frame>
        <target></target>
        <value>608</value>
      </time>
      <time>
        <frame>Feb 2012</frame>
        <target></target>
        <value>615</value>
      </time>
      <time>
        <frame>Mar 2012</frame>
        <target></target>
        <value>683</value>
      </time>
      <time>
        <frame>Apr 2012</frame>
        <target></target>
        <value>519</value>
      </time>
      <time>
        <frame>May 2012</frame>
        <target></target>
        <value>488</value>
      </time>
      <time>
        <frame>Jun 2012</frame>
        <target></target>
        <value>587</value>
      </time>
      <time>
        <frame>Jul 2012</frame>
        <target></target>
        <value>586</value>
      </time>
      <time>
        <frame>Aug 2012</frame>
        <target></target>
        <value>543</value>
      </time>
      <time>
        <frame>Sep 2012</frame>
        <target></target>
        <value>2,734</value>
      </time>
    </fiscal-year>
<fiscal-year>
      <chart-min></chart-min>
      <chart-max></chart-max>
      <title>2013</title>
      <target-header></target-header>
      <target-description></target-description>
      <summary>FY 2013 YTD: 1,365</summary>
      <time>
        <frame>Oct 2012</frame>
        <target></target>
        <value>542</value>
      </time>
      <time>
        <frame>Nov 2012</frame>
        <target></target>
        <value>381</value>
      </time>
      <time>
        <frame>Dec 2012</frame>
        <target></target>
        <value>442</value>
      </time>
      <time>
        <frame>Jan 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Feb 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Mar 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Apr 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>May 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jun 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Jul 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Aug 2013</frame>
        <target></target>
        <value></value>
      </time>
      <time>
        <frame>Sep 2013</frame>
        <target></target>
        <value></value>
      </time>
    </fiscal-year>
  </measure>
  <related-links>
    <link>
      <url>http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm</url>
      <text>FDA-TRACK CDRH Dashboard</text>
    </link>
  </related-links>
  <glossary></glossary>
</measures>਍††਍਍਍਍਍਍਍