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	<title>OrthoSpineNews &#187; Regulatory</title>
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	<description>The latest news for the orthopedic and spine industries</description>
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		<title>DuVal and Associates &#8211; CLIENT ALERT 1/2012</title>
		<link>http://www.orthospinenews.com/duval-and-associates-client-alert-12012</link>
		<comments>http://www.orthospinenews.com/duval-and-associates-client-alert-12012#comments</comments>
		<pubDate>Mon, 16 Jan 2012 17:31:11 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[client alert]]></category>
		<category><![CDATA[duval]]></category>
		<category><![CDATA[FDA]]></category>
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		<description><![CDATA[&#160; In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on the current 510(k) and pre-IDE programs.  We provide some practical insights on what it is like to approach FDA today ...]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>The Future of Healthcare Documentation</title>
		<link>http://www.orthospinenews.com/the-future-of-healthcare-documentation</link>
		<comments>http://www.orthospinenews.com/the-future-of-healthcare-documentation#comments</comments>
		<pubDate>Mon, 16 Jan 2012 16:02:15 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[healthcare documentation]]></category>
		<category><![CDATA[healthcare reform]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=6109</guid>
		<description><![CDATA[When President Obama revealed his dream for a national EMR/EHR system in his 2008 inaugural address, our nation's healthcare providers were given notice that current industry paradigms were under scrutiny, and that change was in the wind. The paper-based medical ...]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Clear as Mud: Obtaining &amp; Marketing your 510(K) with Today&#8217;s FDA</title>
		<link>http://www.orthospinenews.com/clear-as-mud-obtaining-marketing-your-510k-with-todays-fda</link>
		<comments>http://www.orthospinenews.com/clear-as-mud-obtaining-marketing-your-510k-with-todays-fda#comments</comments>
		<pubDate>Mon, 16 Jan 2012 15:19:22 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[duval]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[pictures]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=6098</guid>
		<description><![CDATA[Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal, a national authority on the 510(k) program is in Silver Spring, Md. at FDA nearly twice a month negotiating 510(k) ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/clear-as-mud-obtaining-marketing-your-510k-with-todays-fda/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>The Optimization Process of Electronic Health Records</title>
		<link>http://www.orthospinenews.com/the-optimization-process-of-electronic-health-records</link>
		<comments>http://www.orthospinenews.com/the-optimization-process-of-electronic-health-records#comments</comments>
		<pubDate>Thu, 12 Jan 2012 15:22:25 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[ehr]]></category>
		<category><![CDATA[healthinfoservice]]></category>
		<category><![CDATA[records]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=6088</guid>
		<description><![CDATA[Optimization of your selected EHR system is key to healthy ROI and maximizing its potential benefits; however, it can take months for practices to develop a good, working knowledge of all the functions of their EHR system.  Best outcomes for EHR ...]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>26 Spine Devices Receive FDA 510(k) Clearance in December Featured</title>
		<link>http://www.orthospinenews.com/26-spine-devices-receive-fda-510k-clearance-in-december-featured</link>
		<comments>http://www.orthospinenews.com/26-spine-devices-receive-fda-510k-clearance-in-december-featured#comments</comments>
		<pubDate>Fri, 06 Jan 2012 16:16:05 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[approvals]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[pictures]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=6043</guid>
		<description><![CDATA[The Food and Drug Administration granted 26 spine-related 510(k) clearances in December, according to an FDA report. 1. Acculif TL-PEEK IBF Cage from Coalign Innovations. 2. Renaissance System from Mazor Robotics. 3. Axle PEEK Interspinous Fusion System from X-Spine Systems. 4. Athena Pedicle Screw ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/26-spine-devices-receive-fda-510k-clearance-in-december-featured/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
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		<title>Senate passes bill delaying Medicare physician payment cut for 2 months</title>
		<link>http://www.orthospinenews.com/senate-passes-bill-delaying-medicare-physician-payment-cut-for-2-months</link>
		<comments>http://www.orthospinenews.com/senate-passes-bill-delaying-medicare-physician-payment-cut-for-2-months#comments</comments>
		<pubDate>Tue, 20 Dec 2011 16:34:49 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[healthcare reform]]></category>
		<category><![CDATA[Medicare]]></category>
		<category><![CDATA[ortho supersite]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5976</guid>
		<description><![CDATA[The U.S. Senate passed an amended version of a bill Saturday that postpones a 27.4% Medicarephysician payment decrease scheduled to occur on Jan. 1. The amended measure delays the payment cut and extends the payroll tax deduction and unemployment compensation for ...]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Bill Would Require More Monitoring of Implants</title>
		<link>http://www.orthospinenews.com/bill-would-require-more-monitoring-of-implants</link>
		<comments>http://www.orthospinenews.com/bill-would-require-more-monitoring-of-implants#comments</comments>
		<pubDate>Mon, 19 Dec 2011 16:07:09 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[clinical]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[healthcare reform]]></category>
		<category><![CDATA[monitoring]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5960</guid>
		<description><![CDATA[Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale. The bill would allow ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/bill-would-require-more-monitoring-of-implants/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>4 Insurers Will Supply Health Data</title>
		<link>http://www.orthospinenews.com/4-insurers-will-supply-health-data</link>
		<comments>http://www.orthospinenews.com/4-insurers-will-supply-health-data#comments</comments>
		<pubDate>Tue, 20 Sep 2011 17:30:26 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[data]]></category>
		<category><![CDATA[health insurance]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5778</guid>
		<description><![CDATA[Several major health insurers have agreed to provide their claims data on a regular basis to academic researchers, in an unusual agreement that they say will open a window onto the rising costs of health care. Aetna, Humana, Kaiser Permanente and ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/4-insurers-will-supply-health-data/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Floyd named CEO of Warsaw-based Orthoworx</title>
		<link>http://www.orthospinenews.com/floyd-named-ceo-of-warsaw-based-orthoworx</link>
		<comments>http://www.orthospinenews.com/floyd-named-ceo-of-warsaw-based-orthoworx#comments</comments>
		<pubDate>Tue, 06 Sep 2011 16:55:50 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Appointment]]></category>
		<category><![CDATA[david floyd]]></category>
		<category><![CDATA[education]]></category>
		<category><![CDATA[orthoworx]]></category>
		<category><![CDATA[warsaw]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5742</guid>
		<description><![CDATA[The former worldwide president of DePuy Orthopaedics, David K Floyd, is joining the Warsaw, Indiana-based OrthoWorx as its chief executive officer effective September 6, 2011, according to a press release from OrthoWorx. Floyd, who originally served on the Board of ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/floyd-named-ceo-of-warsaw-based-orthoworx/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>IOM Calls 510(k) Process &#8220;Flawed&#8221;, Recommends FDA Develop New System</title>
		<link>http://www.orthospinenews.com/iom-calls-510k-process-flawed-recommends-fda-develop-new-system</link>
		<comments>http://www.orthospinenews.com/iom-calls-510k-process-flawed-recommends-fda-develop-new-system#comments</comments>
		<pubDate>Mon, 01 Aug 2011 16:39:09 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[iom]]></category>
		<category><![CDATA[mdt]]></category>
		<category><![CDATA[medtronic]]></category>
		<category><![CDATA[pictures]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5627</guid>
		<description><![CDATA[The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the 510(k) was beyond repair and the FDA should just start over. One of ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/iom-calls-510k-process-flawed-recommends-fda-develop-new-system/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review</title>
		<link>http://www.orthospinenews.com/fda-issues-draft-guidance-on-device-changes-that-warrant-new-premarket-review</link>
		<comments>http://www.orthospinenews.com/fda-issues-draft-guidance-on-device-changes-that-warrant-new-premarket-review#comments</comments>
		<pubDate>Tue, 26 Jul 2011 21:00:31 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[device]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5595</guid>
		<description><![CDATA[SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. (Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO) The 510(k) process is the ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/fda-issues-draft-guidance-on-device-changes-that-warrant-new-premarket-review/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Stuart Smalley to Med Device Community &#8220;You&#8217;re Good Enough, You&#8217;re Smart Enough&#8230;&#8221;</title>
		<link>http://www.orthospinenews.com/stuart-smalley-to-med-device-community-youre-good-enough-youre-smart-enough</link>
		<comments>http://www.orthospinenews.com/stuart-smalley-to-med-device-community-youre-good-enough-youre-smart-enough#comments</comments>
		<pubDate>Thu, 23 Jun 2011 18:15:59 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[Health Care Reform]]></category>
		<category><![CDATA[pictures]]></category>
		<category><![CDATA[senate]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5554</guid>
		<description><![CDATA[Sen. Franken to Top FDA Official: Seek Medical Device Community’s Expertise Before Changing Approval Process for New Products WASHINGTON, D.C. [06/23/11] – U.S. Sen. Al Franken (D-Minn.) on Tuesday urged a top official at the Food and Drug Administration (FDA) ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/stuart-smalley-to-med-device-community-youre-good-enough-youre-smart-enough/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Medical device review took the FDA 37% longer in 2010 than 2006</title>
		<link>http://www.orthospinenews.com/medical-device-review-took-the-fda-37-longer-in-2010-than-2006</link>
		<comments>http://www.orthospinenews.com/medical-device-review-took-the-fda-37-longer-in-2010-than-2006#comments</comments>
		<pubDate>Thu, 23 Jun 2011 16:01:43 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[510k]]></category>
		<category><![CDATA[Approval]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[ide]]></category>
		<category><![CDATA[pictures]]></category>
		<category><![CDATA[process]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5551</guid>
		<description><![CDATA[MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food &#38; Drug Administration's medical device application review, finding that application times jumped 37 percent from 2006 to 2010. Emergo reviewed the ...]]></description>
		<wfw:commentRss>http://www.orthospinenews.com/medical-device-review-took-the-fda-37-longer-in-2010-than-2006/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Yeah, Sure&#8230; Like We Are Going To Believe That</title>
		<link>http://www.orthospinenews.com/yeah-sure-like-we-are-going-to-believe-that</link>
		<comments>http://www.orthospinenews.com/yeah-sure-like-we-are-going-to-believe-that#comments</comments>
		<pubDate>Thu, 02 Jun 2011 22:59:29 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[europe]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[healthcare reform]]></category>
		<category><![CDATA[pictures]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5488</guid>
		<description><![CDATA[FDA device chief Shuren: Recession played a role in pushing medical device industry to EU Dr. Jeffrey Shuren tells a U.S. House panel that the recession created a more "risk-averse" investment environment that helped push medical device companies to launch ...]]></description>
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		<slash:comments>3</slash:comments>
		</item>
		<item>
		<title>Let The Games Begin</title>
		<link>http://www.orthospinenews.com/let-the-games-begin</link>
		<comments>http://www.orthospinenews.com/let-the-games-begin#comments</comments>
		<pubDate>Fri, 27 May 2011 17:07:12 +0000</pubDate>
		<dc:creator>Josh Sandberg</dc:creator>
				<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[featured]]></category>
		<category><![CDATA[pictures]]></category>
		<category><![CDATA[pod's]]></category>
		<category><![CDATA[spineblogger]]></category>

		<guid isPermaLink="false">http://www.orthospinenews.com/?p=5461</guid>
		<description><![CDATA[The Martin Memorial Health Systems in the State of Florida issued a memorandum dated May 6th, 2011 to all of its providers of medical devices and supplies.  The reference on the memo was regarding PODS. Here is a reprint of ...]]></description>
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