EAP Program by the FDA is to:
- Speed qualifying devices to patients without compromising FDA’s high standards for safety and effectiveness.
- The program will be available to sponsors from April 15.
- The timeline to respond to such requests is 30 days and if the FDA asks for additional information, the decision cannot be delayed by no later than 30 more days.
- Being an EAP designated project will grant early collaboration for sponsor with CDRH staff to develop a Data Development Plan with the agency.
- The Data Development Plan will allow sponsors to understand the type of data expected and also reduce the burden of premarket data collection to postmarket surveillance.
- EAP designation may also tilt the risk-benefit balance in favor of approval if there is a strong unmet need for the device.
- If enough information is not provided within this timeframe, FDA will deny the EAP request.
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