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	<id>http://glossary.i-hts.org/index.php?action=history&amp;feed=atom&amp;title=Investigational_device_exemption_%28IDE%29</id>
	<title>Investigational device exemption (IDE) - Revision history</title>
	<link rel="self" type="application/atom+xml" href="http://glossary.i-hts.org/index.php?action=history&amp;feed=atom&amp;title=Investigational_device_exemption_%28IDE%29"/>
	<link rel="alternate" type="text/html" href="http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;action=history"/>
	<updated>2026-10-20T09:56:44Z</updated>
	<subtitle>Revision history for this page on the wiki</subtitle>
	<generator>MediaWiki 1.40.1</generator>
	<entry>
		<id>http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=786&amp;oldid=prev</id>
		<title>Admin1 at 13:03, 21 November 2023</title>
		<link rel="alternate" type="text/html" href="http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=786&amp;oldid=prev"/>
		<updated>2023-11-21T13:03:53Z</updated>

		<summary type="html">&lt;p&gt;&lt;/p&gt;
&lt;table style=&quot;background-color: #fff; color: #202122;&quot; data-mw=&quot;interface&quot;&gt;
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				&lt;td colspan=&quot;2&quot; style=&quot;background-color: #fff; color: #202122; text-align: center;&quot;&gt;← Older revision&lt;/td&gt;
				&lt;td colspan=&quot;2&quot; style=&quot;background-color: #fff; color: #202122; text-align: center;&quot;&gt;Revision as of 15:03, 21 November 2023&lt;/td&gt;
				&lt;/tr&gt;&lt;tr&gt;&lt;td colspan=&quot;2&quot; class=&quot;diff-lineno&quot; id=&quot;mw-diff-left-l3&quot;&gt;Line 3:&lt;/td&gt;
&lt;td colspan=&quot;2&quot; class=&quot;diff-lineno&quot;&gt;Line 3:&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&amp;#039;&amp;#039;&amp;#039;Note:&amp;#039;&amp;#039;&amp;#039; The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]].&lt;/div&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&amp;#039;&amp;#039;&amp;#039;Note:&amp;#039;&amp;#039;&amp;#039; The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]].&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot; data-marker=&quot;−&quot;&gt;&lt;/td&gt;&lt;td style=&quot;color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&lt;del style=&quot;font-weight: bold; text-decoration: none;&quot;&gt;[&lt;/del&gt;http://htaglossary.net/investigational-device-exemption-(IDE)&lt;del style=&quot;font-weight: bold; text-decoration: none;&quot;&gt;]&lt;/del&gt;&lt;/div&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot; data-marker=&quot;+&quot;&gt;&lt;/td&gt;&lt;td style=&quot;color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&lt;ins style=&quot;font-weight: bold; text-decoration: none;&quot;&gt;== Reference ==&lt;/ins&gt;&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td colspan=&quot;2&quot; class=&quot;diff-side-deleted&quot;&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot; data-marker=&quot;+&quot;&gt;&lt;/td&gt;&lt;td style=&quot;color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;http://htaglossary.net/investigational-device-exemption-(IDE)&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;/table&gt;</summary>
		<author><name>Admin1</name></author>
	</entry>
	<entry>
		<id>http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=390&amp;oldid=prev</id>
		<title>Editor iHTS at 10:06, 9 November 2023</title>
		<link rel="alternate" type="text/html" href="http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=390&amp;oldid=prev"/>
		<updated>2023-11-09T10:06:52Z</updated>

		<summary type="html">&lt;p&gt;&lt;/p&gt;
&lt;table style=&quot;background-color: #fff; color: #202122;&quot; data-mw=&quot;interface&quot;&gt;
				&lt;col class=&quot;diff-marker&quot; /&gt;
				&lt;col class=&quot;diff-content&quot; /&gt;
				&lt;col class=&quot;diff-marker&quot; /&gt;
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				&lt;tr class=&quot;diff-title&quot; lang=&quot;en&quot;&gt;
				&lt;td colspan=&quot;2&quot; style=&quot;background-color: #fff; color: #202122; text-align: center;&quot;&gt;← Older revision&lt;/td&gt;
				&lt;td colspan=&quot;2&quot; style=&quot;background-color: #fff; color: #202122; text-align: center;&quot;&gt;Revision as of 12:06, 9 November 2023&lt;/td&gt;
				&lt;/tr&gt;&lt;tr&gt;&lt;td colspan=&quot;2&quot; class=&quot;diff-lineno&quot; id=&quot;mw-diff-left-l1&quot;&gt;Line 1:&lt;/td&gt;
&lt;td colspan=&quot;2&quot; class=&quot;diff-lineno&quot;&gt;Line 1:&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness.&lt;/div&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness.&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot; data-marker=&quot;−&quot;&gt;&lt;/td&gt;&lt;td style=&quot;color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&#039;&#039;&#039;Note:&#039;&#039;&#039; The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]].&lt;del style=&quot;font-weight: bold; text-decoration: none;&quot;&gt;#&lt;/del&gt;&lt;/div&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot; data-marker=&quot;+&quot;&gt;&lt;/td&gt;&lt;td style=&quot;color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;&#039;&#039;&#039;Note:&#039;&#039;&#039; The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]].&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;br/&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;tr&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;[http://htaglossary.net/investigational-device-exemption-(IDE)]&lt;/div&gt;&lt;/td&gt;&lt;td class=&quot;diff-marker&quot;&gt;&lt;/td&gt;&lt;td style=&quot;background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;&quot;&gt;&lt;div&gt;[http://htaglossary.net/investigational-device-exemption-(IDE)]&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;
&lt;/table&gt;</summary>
		<author><name>Editor iHTS</name></author>
	</entry>
	<entry>
		<id>http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=389&amp;oldid=prev</id>
		<title>Editor iHTS: Created page with &quot;A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness.  &#039;&#039;&#039;Note:&#039;&#039;&#039; The data thus collected may be used subsequently in a premarketing approval application.#  [http://htaglossary.net/investigational-device-exemption-(IDE)]&quot;</title>
		<link rel="alternate" type="text/html" href="http://glossary.i-hts.org/index.php?title=Investigational_device_exemption_(IDE)&amp;diff=389&amp;oldid=prev"/>
		<updated>2023-11-09T10:06:41Z</updated>

		<summary type="html">&lt;p&gt;Created page with &amp;quot;A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness.  &amp;#039;&amp;#039;&amp;#039;Note:&amp;#039;&amp;#039;&amp;#039; The data thus collected may be used subsequently in a &lt;a href=&quot;/index.php?title=Premarketing_approval_application_(PMA)&quot; title=&quot;Premarketing approval application (PMA)&quot;&gt;premarketing approval application&lt;/a&gt;.#  [http://htaglossary.net/investigational-device-exemption-(IDE)]&amp;quot;&lt;/p&gt;
&lt;p&gt;&lt;b&gt;New page&lt;/b&gt;&lt;/p&gt;&lt;div&gt;A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness.&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;Note:&amp;#039;&amp;#039;&amp;#039; The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]].#&lt;br /&gt;
&lt;br /&gt;
[http://htaglossary.net/investigational-device-exemption-(IDE)]&lt;/div&gt;</summary>
		<author><name>Editor iHTS</name></author>
	</entry>
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