FDA program to speed approval of devices for unmet needs

The U.S. Food and Drug Administration is creating a voluntary program, the Expedited Access Program (EAP), to speed medical devices to patients who have life-threatening conditions while not compromising FDA's safety standards, according to a blog post on the agency's website.

Through the program, device sponsors that "meet an unmet need" can request EAP designation, writes Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. In addition, he says, the Center for Devices and Radiological Health will work more closely with device makers.

The FDA also will create a Data Development Plan, which will "provide predictability and leverages postmarket data collection," Shuren says.

The program will be running by April 15. Blog post