For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:
If there is no time for the written form, a physician can request access via telephone or other rapid means. Wait For Access
Submitting IND safety reports for any adverse events. For medical devices, the Expedited Access PMA (EAP)
The patient must have a or severely debilitating disease or condition. For medical devices