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FDA proposes program to speed approval of medical devices
Reuters

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.

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