As of April 15, 2015, the U.S. Food and Drug Administration (FDA) has opened a fast track route for medical device approval called the Expedited Access Pathway (EAP) program. This program will both expedite approval and require less data for certain life saving devices. In return, the device sponsor will need to conduct thorough studies and post-market surveillance on the device to ensure safety and efficacy.
For a medical device to qualify under the EAP, it must treat or diagnose a life threatening or irreversibly debilitating disease or condition. It must also show “reasonable” assurance of safety and efficacy. Furthermore, the medical device should provide a technological advantage over current products and/or address unmet clinical need in terms of treatment or means of diagnosis.
The medical device sponsor should request EAP designation from the FDA prior to starting an investigational device exemption study. The FDA will accept requests for de novo classification (for lower risk devices) as well as Premarket Approval Applications (PMAs) under the EAP. However, 510(k) applications will not be eligible for this program.
On April 22, 2015, the FDA released a draft guidance to update the standards for the acceptance of clinical study data from outside the U.S. The document stresses ensuring validity of scientific evidence and protection of trial patients. Trial sponsors hoping to use data generated entirely outside of the U.S. should seek input from the FDA as early as possible through a pre-submission meeting.