FDA-EXPEDITED-ACCESS › 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
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
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Document Number
FDA-EXPEDITED-ACCESS
Revision Level
2015 EDITION
Status
Current
Publication Date
April 13, 2015
Page Count
44 pages