FDA program aims to expedite access to high-risk medical devices

The FDA announced today that it has proposed a new program to help patients with life-threatening or seriously debilitating illnesses gain expedited access to medical devices in early trial stages, particularly if the device addresses an unmet medical need. The proposed program, known as Expedited Access PMA (EAP), builds on the FDA’s Innovation Pathway initiative launched in 2011, which is designed to reduce the length of time needed “to develop safe and effective products” and to facilitate greater collaboration between device manufacturers and the FDA.

Full Story →