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The Burrill Report (August 15, 2011): Med Device Industry Balks at IOM Advice to FDA (.MP3,12.38 Mb)
The Institute of Medicine at the end of July issued a report that calls for the U.S. Food and Drug Administration to scrap a 35-year-old process for approving medical devices not considered to be high-risk. The report says the current process cannot assure that devices reaching the market are safe and effective. We spoke to Steve Ubl, president and CEO of the medical device trade group AdvaMed, about the report, why the industry thinks the IOM got it wrong, and where the FDA goes from here on revamping its approach to regulating medical devices.
August 11, 2011
http://www.burrillreport.com/article-med_device_industry_balks_at_iom_advice_to_fda_.html
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Med Device Industry Balks at IOM Advice to FDA
Podcast: August 15, 2011[Please login to post comments]
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