FDA-EXPEDITED-ACCESS Complete Document History
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff

Complete Current Edition:
   2015 EDITION - Guidance for Industry and Food and Drug Administration Staff - April 13, 2015

Obsolete Revision Information:
   2014 DRAFT - Draft Guidance for Industry and Food and Drug Administration - April 23, 2014