Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet MedicalNeed for Life Threatening or Irreversibly Debilitating Diseases or Conditions: Guidance for Industry and Food and Drug Administration Staff.

摘要

The Food and Drug Administration (FDA or the Agency) is introducing a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMAs) or de novo requests. FDA believes that the “Expedited Access Pathway for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions” (“Expedited Access Pathway” or “EAP”) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval1 and the statutory standards for granting a de novo request2 consistent with the Agency’s statutory mission to protect and promote public health.