This program allows for with the FDA during development to reduce time to market.
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
A physician requesting access for an individual patient takes on the role of a and must handle legal and safety requirements: This program allows for with the FDA during
Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access : 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)