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

FDA-EXPEDITED-ACCESS - 2015 EDITION - CURRENT
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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