CDRH Industry: Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff

A draft guidance for Industry and U.S. Food and Drug Administration Staff about Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions has recently been posted.  The Food and Drug Administration (FDA or the Agency) is proposing 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 (PMA) applications. FDA believes that the "Expedited Access PMA for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions" ("Expedited Access PMA" 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 approval, consistent with the Agency’s statutory mission to protect and promote public health. For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm393879.htm