The FDA has finalized plans for an accelerated review program for critical medical devices, and said it will begin accepting applications to participate in the new pathway on April 15.

The program applies to devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” Examples include of previous devices that would meet the condition include the first drug-coated balloon catheter to treat vascular disease.

EAP guidance
article in Fierce Biotech