July 2, 2014
The FDA proposes a new fast track program to approve high-risk medical devices for diagnosis or treatment of serious diseases for which no technology currently exists. Built on the Innovation Pathway, the Expedited Access PMA (EAP) guidance document issued in April this year recommends pre-market approval to provide patients with early access to safe and effective medical devices.
An addition to the FDA’s existing four fast track programs – Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review – for speedier development and review of new products to address unmet therapeutic needs, the EAP requires medical devices to address life-threatening conditions. Devices under investigation must represent novel and breakthrough technologies with a marked benefit for patients over existing products.
The EAP emphasizes the need for collaboration between the FDA and sponsors to expedite product development according to FDA safety and efficacy standards. If the product receives early approval, the FDA requires sponsors to collect post-market data for device risk/benefit assessment to strengthen patient safety.