As part of the EAP program, FDA intends to provide more interactive communications during device development and more interactive review of Investigational Device Exemption applications, PMA applications, and requests for de novo review. This includes working with the sponsor to create a data development plan specific to the device, which would outline all data the sponsor intends to collect in support of device approval, and identifying what data would be collected premarket and postmarket.
FDA has released a guidance document outlining the details of the EAP program: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Needfor Life Threatening or Irreversibly Debilitating Diseases or Conditions.
? Email us at firstname.lastname@example.org if you have further questions about the expedited access program for PMA and De Novo process. Ref: EAP Program