For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:
Complete and submit this form to the FDA to request individual patient expanded access. Wait For Access
1. Eligibility Assessment
If there is no time for the written form, a physician can request access via telephone or other rapid means. For medical devices, the Expedited Access PMA (EAP)
Identify investigational drugs or devices that have shown promise in clinical trials but are not yet on the market. For medical devices
Maintaining all required records and reports for the duration of the treatment.