FDA launches Expedited Access Pathway program for devices

The FDA has introduced its Expedited Access Pathway Program, a voluntary program designed to reduce the time from development to marketing decision for certain lifesaving medical devices, the agency said on its website.Under the program, sponsors of devices to treat life-threatening or debilitating conditions that address an unmet need can request an Expedited Access Pathway (EAP) designation. The FDA’s Center for Devices and Radiological Health (CDRH) will work with developers of these devices to decrease the time and cost to bring these devices to the market. The CDRH will collaborate with device manufacturers to establish a Data Development Plan, which will transfer premarket data collection to the postmarket setting, where appropriate, while still meeting the FDA’s approval standard of reasonable assurance of safety and effectiveness.