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Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

FDA-FACTORS-IDE - 2015 DRAFT - SUPERSEDED
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Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff


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Document Number

FDA-FACTORS-IDE

Revision Level

2015 DRAFT

Status

Superseded

Publication Date

June 18, 2015

Page Count

36 pages