FDA Proposes Program for Faster Approval of Medical Devices

The U.S. Food and Drug Administration proposed on Tuesday a more collaborative approach aimed at speeding up marketing approval for high-risk medical devices intended to treat patients with serious conditions that have no other treatment options.

The proposed Expedited Access Premarket Approval Application program would feature earlier and more frequent interactions between companies and FDA staff.

The proposal is a response to criticisms by policymakers, patient groups and the industry that the FDA’s process for approving medical devices is inefficient and slow, thereby denying patients access to new, helpful products.

The program is not a new pathway to market, the FDA said, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market.