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FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
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Document Number
FDA-2011-D-0790
Revision Level
2011 DRAFT
Status
Superseded
Publication Date
Nov. 10, 2011
Page Count
15 pages