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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2003-12-18/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Sun, Nov 23 2008 11:00:00 GMT</pubDate>
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    <item>
  <title><![CDATA[Neurological Devices; Classification of Human Dura Mater ]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-18-03-31174</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is classifying human
dura mater intended to repair defects in human dura mater into class II
(special controls). This action is being taken to establish sufficient
regulatory control to provide reasonable assurance of the safety and
effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
entitled ``Class II Special Controls Guidance Document: Human Dura
Mater'' that will serve as the special control for this device.
Dates: This rule is effective January 20, 2004.
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  <guid>http://thefederalregister.com/d.p/2003-12-18-03-31174</guid>
  <pubDate>Thu, Dec 18 2003 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[Advisory Committee Information Hotline ]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-18-03-31157</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that we
have revised the Advisory Committee Information Hotline (the hotline).
The hotline provides the public with access to the most current
information available on FDA advisory committee meetings. This notice
supersedes all previously published announcements of FDA's Advisory
Committee Information Hotline.
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  <guid>http://thefederalregister.com/d.p/2003-12-18-03-31157</guid>
  <pubDate>Thu, Dec 18 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-18-03-31175</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Human Dura Mater.'' This guidance document describes a means<br/> [[Page 70514]]<br/>
by which human dura mater may comply with the requirement of special
controls for class II devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule to classify this device type
into class II (special controls).
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  <guid>http://thefederalregister.com/d.p/2003-12-18-03-31175</guid>
  <pubDate>Thu, Dec 18 2003 11:00:00 GMT</pubDate>
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