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2014 DRAFT - Draft Guidance for Industry and Food and Drug Administration - April 23, 2014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