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)
Maintaining all required records and reports for the duration of the treatment.
For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases: Wait For Access
If there is no time for the written form, a physician can request access via telephone or other rapid means.
It focuses on moving devices through the premarket review process faster if they demonstrate a breakthrough potential. Once access is granted, the physician is responsible for: Obtain written informed consent from the patient as
Physicians often have the most up-to-date knowledge on which manufacturers are developing new therapies. 3. Obtaining Manufacturer Authorization
1. Eligibility Assessment
A physician requesting access for an individual patient takes on the role of a and must handle legal and safety requirements:
