For medical devices, the Expedited Access PMA (EAP) program is designed for devices addressing unmet needs for life-threatening diseases:
The physician must contact the manufacturer to request the drug.
Use databases like ClinicalTrials.gov to find active studies. Wait For Access
If the manufacturer agrees, they must provide an LOA stating they will supply the drug for that specific patient. 4. Physician Responsibilities (Sponsor-Investigator)
1. Eligibility Assessment
This program allows for with the FDA during development to reduce time to market.
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)
The patient must have a or severely debilitating disease or condition.