Emergency Use of an Unapproved Investigational Device Policy and ...
10/20/2014
a) emergency use must meet criteria as a clinical investigation of a test article ... clinical investigation may certify in writing stipulations as noted in 21 CFR 50.23( a). 2. ... If an IDE application for subsequent use has been filed with FDA and FDA ...
research.uthscsa.eduEmergency Use of an Unapproved Investigational Device Policy and ...
Emergency Use - Institutional Review Board - University of Pittsburgh
Neil Strauss - Wikipedia, the free encyclopedia
Effect of patients seeing a general practitioner in accident and ...
055 Pa. Code § 3270.27. Emergency plan.
(IND) or Investigational Device Exemption (IDE) - Yale University
Stanford IRB - Emergency Use of a Test Article
FDA: Emergency Exemption from Prospective IRB Approval for ...