For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:
Identify investigational drugs or devices that have shown promise in clinical trials but are not yet on the market. 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)
Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access : For medical devices
This program allows for with the FDA during development to reduce time to market.
1. Eligibility Assessment
The physician must contact the manufacturer to request the drug.