Comments on: Spinal fusion device draws FDA warning letter http://medcitynews.com/2012/03/spinal-fusion-device-draws-fda-warning-letter/ Unique business news on biotech companies, new innovative medical devices Fri, 24 May 2013 16:03:22 +0000 hourly 1 http://wordpress.org/?v=3.5.1 By: Erin http://medcitynews.com/2012/03/spinal-fusion-device-draws-fda-warning-letter/comment-page-1/#comment-362148 Erin Thu, 29 Mar 2012 16:05:48 +0000 http://www.medcitynews.com/?p=132598#comment-362148 It is misleading to say that Warning Letters are informal and do not necessarily indicate that FDA will take punitive damages. Warning letters require an adequate response within 15 days or else FDA will take further actions. While under a Warning Letters, certificates to foreign government will not be issued by the FDA for that company, which hampers international registrations. In addition, FDA will not approve new devices unless there is a significant medical need for such a device.

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