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FDA proposes program for faster approval of medical device

Reuters, April 23, 2014
The U.S. Food and Drug Administration on Tuesday proposed speeding up medical device approvals for patients who have no other treatment options through a new program focused on earlier and more frequent interactions between companies and FDA staff. The Expedited Access Premarket Approval Application program is a response to criticisms by policymakers, patient groups and industry that the FDA process for approving medical devices is inefficient and slow, delaying patients' access to new, helpful products. The program is not a new pathway to market, the agency said, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market.