For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:
Obtain written informed consent from the patient as per 21 CFR §50.25, ensuring they understand the risks of an unapproved treatment. 5. Expedited Access Programs (Medical Devices) Wait For Access
The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer. For medical devices, the Expedited Access PMA (EAP)
A physician requesting access for an individual patient takes on the role of a and must handle legal and safety requirements: For medical devices
The patient must have a or severely debilitating disease or condition.