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FDA proposes tighter rules for emergency defibrillators

Started by riky, March 24, 2013, 08:00:21 AM

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riky

FDA proposes tighter rules for emergency defibrillators

<p><a href="http://news.yahoo.com/fda-proposes-tightening-rules-heart-defibrillators-150903969.html"><img src="http://l1.yimg.com/bt/api/res/1.2/4Zss1b2I8tp17TzYo270lQ--/YXBwaWQ9eW5ld3M7Zmk9ZmlsbDtoPTg2O3E9ODU7dz0xMzA-/http://media.zenfs.com/en_us/News/Reuters/2013-03-22T193019Z_1_CBRE92L1I6P00_RTROPTP_2_CHINA-PHARMACEUTICALS.JPG" width="130" height="86" alt="A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring" align="left" title="A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring" border="0" /></a>By Toni Clarke (Reuters) - The U.S. Food and Drug Administration is proposing new rules aimed at improving the reliability of emergency defibrillators following some 45,000 reports of device failures over the past seven years. The defibrillators, found in hundreds of airports, shopping malls and restaurants across the country, are designed to jump-start the heart after it has suddenly stopped. The FDA said its proposal would require manufacturers to provide clinical data or other evidence proving their devices are safe and effective in order to be approved or remain on the market. ...</p><br clear="all"/>

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