The U.S. Food and Drug Administration proposed on Tuesday a new, more collaborative approach for faster approval of high-risk medical devices intended to treat patients with serious conditions with no other treatment options.
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The proposed program, called Expedited Access Premarket Approval Application, would feature earlier and more interactions with FDA staff. (http://r.reuters.com/kaw68v)
The program is not a new pathway to market, but rather a collaborative approach to reduce the time associated with product development, the FDA said.