New Expedited Access Program – PMA and De Novo

15 Apr

New Expedited Access Program – PMA and De Novo

Attention!!! Clients are being notified that FDA’s Expedited Access Pathway (EAP) Program for Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions became effective on April 15, 2015. FDA believes that the EAP program will help patients have more timely access to medical devices intended for unmet medical need for life threatening or irreversibly debilitating diseases or conditions medical devices by expediting their development, assessment, and review.

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 [email protected] if you have further questions about the expedited access program for PMA and De Novo process. Ref: EAP Program

New Expedited Access Program – PMA and De Novo