Access - Wait For

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) program is designed for devices addressing unmet needs for life-threatening diseases: Wait For Access

Physicians often have the most up-to-date knowledge on which manufacturers are developing new therapies. 3. Obtaining Manufacturer Authorization The FDA cannot compel a company to provide

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: Wait For Access

Submitting IND safety reports for any adverse events.

Complete and submit this form to the FDA to request individual patient expanded access.

This program allows for with the FDA during development to reduce time to market.