Rare Disease Device Review Changes Coming in Next Year, FDA Says

A broken program that keeps new medical devices out of the hands of patients with rare diseases will get an overhaul in the coming year, the FDA’s top device official said.

“The regulatory pathway just isn’t right,” Jeffrey Shuren, director of the Center for Devices and Radiological Health in the Food and Drug Administration, said Oct. 22. “It makes it too challenging, and the incentives just aren’t there.”

The FDA’s Humanitarian Device Exemption is supposed to make it easier for medical device companies to win approvals for new products to treat rare diseases. Devices approved under that process don’t have ...