The program allows for a collaborative approach to help manufacturers with product development and evaluation. The FDA’s resources and focus on the technologies in the EAP program allow more efficient product evaluation and market entry, providing more options for patients who have a critical need for the devices.
Projects must meet the following criteria to qualify for the EAP program:
- The device should treat or diagnose a life-threatening or irreversibly debilitating disease or condition
- The device should address an unmet need, which is usually shown by comparing the device to other available options
- The company should have a Data Development Plan outlining what will be included in future submissions to FDA
Over the past year, the FDA has made 29 decisions on requests for EAP designation — 17 were accepted into the program and 12 were denied.
EAP designation requests have included devices for the heart, brain and kidneys, manufactured by small startup companies and larger corporations. Products in the EAP program ultimately undergo either premarket approval or de novo review.
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