FDA-FACTORS-IDE Complete Document History
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

Complete Current Edition:
   2017 EDITION - Guidance for Investigational Device Exemption Sponsors, Spon - Jan. 13, 2017

Obsolete Revision Information:
   2015 DRAFT - Draft Guidance for Investigational Device Exemption Sponsors - June 18, 2015