The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo requests. FDA formally established the EAP program through a final guidance document titled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions” (hereafter, EAP Guidance), issued on April 13, 2015.

The EAP Guidance states that the EAP program is based in part on the expedited review and approval programs for new drug products that are intended to address unmet medical needs in the treatment of serious or life-threatening conditions. The development of the EAP program is also informed by the Center for Devices and Radiological Health’s Innovations Pathway, piloted in 2011 and intended to facilitate the development and expedite the review of breakthrough technologies. The EAP framework, adopted for PMA and de novo devices, works in conjunction with FDA’s existing processes for making benefit-risk determinations for medical devices and authorities for requiring postmarket data collection and reporting. The EAP Guidance explains how FDA applies these existing processes through the EAP program to “help patients have more timely access to [certain PMA and de novo devices] by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval . . . .”