Ongoing Review

​Emergency Use of a Test Article in a Life-Threatening Situation

If there is an emergency use of a test article in a life-threatening situation (as defined in
21CFR 312.81(a)1-2, 21CFR 812.36(a) or Medical Devices Regulations SOR/98-282), Schulman requires descriptive and detailed documentation concerning the use. The
Emergency Use of a Test Article in a Life-Threatening Situation Report Form must be completed and submitted as directed.