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	<title>Five-Ten Blog</title>
	<link>http://my510k.com/fivetenblog</link>
	<description>Social Media in the Medical Device World</description>
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		<title>FDA asks Device Makers&#8230;But, what about the kids!?!</title>
		<description><![CDATA[Did you forget something on your premarket approval application?  Check it twice, because the rules have changed&#8230;again.  The FDA is now requiring manufacturers of medical devices to include pediatric patient information with all premarket approval submissions.  The Agency has even said that they may withhold approval of any applications missing such data, until the required [...]]]></description>
		<link>http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids</link>
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		<title>Common Themes of Change in 510(k) Comments</title>
		<description><![CDATA[If you want to know what changes may be in store for medical device approvals, look no further.  Change is coming, and it looks like it will start with &#8220;substantial equivalence&#8221;.  Since the Premarket Notification (510k) has been established, medical device approvals have centered around the idea of substantial equivalence to a predicate device.  Substantial equivalence means that [...]]]></description>
		<link>http://my510k.com/fivetenblog/fda/common-themes-of-change-in-510k-comments</link>
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		<title>Medical Device Community my510k.com Beta now Open</title>
		<description><![CDATA[Earlier this year, my510k.com was founded on an idea, to extend the conversations I had been having with colleagues in the medical device community. It seems that there are few places online to connect and collaborate about the ongoing issues regarding the industry, government, and the world market for medical technology.
Many of the stories in the [...]]]></description>
		<link>http://my510k.com/fivetenblog/uncategorized/medical-device-community-my510k-com-beta-now-open</link>
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		<title>Defending &#8220;Zucker-punches&#8221; From 510(k) Critic</title>
		<description><![CDATA[It seems lately, the thing to do when one fails to achieve their desired result, is cry foul.  This can be true whether you&#8217;re an Olympic ice skater or a health policy leader.  This conclusion comes after reading the post from MassDevice interviewing Diana Zuckerman, about the recent FDA meeting reviewing the 510(k) process for clearing medical devices.  Diana Zuckerman is the president [...]]]></description>
		<link>http://my510k.com/fivetenblog/industry-news/defending-zucker-punches-from-510k-critic</link>
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		<title>FDA Meeting on 510(k) Highlights Differing Views</title>
		<description><![CDATA[Much has changed in the FDA over the past year, and it appears more change is to come.  Issues surrounding device approvals under the 510(k) process were front-and-center in a public meeting this past Thursday.  The meeting was titled by the FDA, &#8220;Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process&#8221; and [...]]]></description>
		<link>http://my510k.com/fivetenblog/fda/fda-meeting-on-510k-highlights-differing-views</link>
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		<title>Medical Device Makers Care for the Olympics</title>
		<description><![CDATA[While the games are underway, bringing stories both great and tragic from the mountains of Vancouver, there is an unsung chronicle of the technology supporting these athletes in their quest for Olympic Gold.   The Vancouver Olympic Committee estimates $5 million in medical equipment/supplies have been donated for the Games in 2010.  In [...]]]></description>
		<link>http://my510k.com/fivetenblog/industry-news/med-device-makers-care-for-the-olympics</link>
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		<title>Faster Clinical Trials in Plain English</title>
		<description><![CDATA[Before all this talk of &#8220;Snowmaggedon&#8221;, a beaming headline posted late last week stating that, &#8220;FDA Issues Guidance to Help Streamline Medical Device Clinical Trials&#8221;.  If you were hoping to learn how it works, you were in for a statistics lesson on Bayesian methods for designing studies and analyzing clinical data.  (Wait, don&#8217;t leave!)  Good [...]]]></description>
		<link>http://my510k.com/fivetenblog/fda/faster-clinical-trials-in-plain-english</link>
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		<title>Off-Label Use in FDA Crosshairs</title>
		<description><![CDATA[&#8220;How many should I take?&#8221;  &#8220;What level should I set my device to?&#8221;  &#8220;How long should I use the therapy?&#8221;  Many of these questions are answered in product labeling.  Labeling is all about specifying the &#8220;intended use&#8221; of the product.  The FDA has always enforced limits on labeling in all of its forms.  As the [...]]]></description>
		<link>http://my510k.com/fivetenblog/industry-news/off-label-use-in-fda-crosshairs</link>
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		<title>Groundhog Day at the FDA</title>
		<description><![CDATA[It seems like all of this new talk about reform and tightening regulations at the FDA will usher in a brave new world for the medical device industry.  Should we be worried or hopeful about pending changes to the health care system and the regulatory approval process?  To find the answer, we need only look [...]]]></description>
		<link>http://my510k.com/fivetenblog/fda/groundhog-day-at-the-fda</link>
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		<title>State of the Medical Device Industry</title>
		<description><![CDATA[Before an hour had even passed, last night&#8217;s State of the Union address was already being analyzed and scrutinized in many different ways from a political standpoint.  Taking a closer look at the comments made by President Obama, it is interesting to see the implications this speech has for the continued health of the Medical [...]]]></description>
		<link>http://my510k.com/fivetenblog/industry-news/state-of-the-medical-device-industry</link>
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