FDA proposes program to speed approval of medical devices

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FDA proposes program to speed approval of medical devices

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. It is similar to a new FDA program intended to expedite development of certain cancer drugs in the clinical trial stage, Morningstar analyst Debbie Wang said. "This is yet another aspect of how FDA is trying to work in a more coordinated fashion so they can reduce the number of false starts and situations of reinventing the wheel, and to help put some priority on which therapies are going to affect the most patients with the greatest need," Wang said.

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