Expedited Access for Premarket Approval (EAP) Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance

FDA Draft Guidance: Expedited Access for Premarket Approval (EAP) Medical Devices On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.

The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading