For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...
FDA and the University IRB recognize there may be circumstances for a health care provider to use an unapproved or investigational device to save the life of a patient or to help a patient suffering ...
Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
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