Wait For Access [iOS]

For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:

Maintaining all required records and reports for the duration of the treatment. Wait For Access

Use databases like ClinicalTrials.gov to find active studies. For medical devices, the Expedited Access PMA (EAP)

Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access : For medical devices

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:

1. Eligibility Assessment