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Regulation and Access to Innovative Medical Technologies

The current environment is rife with debate calling for FDA and EU reform of the regulatory process for medical devices. One side views the processes for reviewing new medical technologies in the U.S. and Europe as too industry-centric and believes that speed to approval is valued over risk. The other side of the debate worries that the slowing pace of device approvals in the U.S. is creating an increasing gap between Europe and the U.S. Yet there is relatively little robust, comprehensive data on the trends in medical device regulation. In particular, little information exists on whether the phenomenon of earlier approval of certain medical technologies in Europe is a new development, or whether this is something that has been in effect for some time.

Posted on 01.06.2012