dijous, 24 d’abril del 2014

FDA offers expedited U.S. market pathway for some high-risk devices




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





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By Stewart Eisenhart, Emergo Group


A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies.




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