expedited access pma

FDA to Accept Applications for Expedited Medical Device Approval

April 13, 2015 / in usability testing , user-centered design , design science , EAP , Expedited Access PMA , FDA , guidance , healthcare , human factors , industrial design , medical product design , news / by Christina S

On April 15th, the Food and Drug Administration will begin accepting applicants through its new Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”). Read more

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