Evaluation of unanticipated adverse device effects (uades) must be reported to the fda by the:

1 answer:

5 0

Evaluation of unanticipated adverse device effects (UADDEs) must be reported to the FDA by the IRB and all investigators participating in the test of the product within ten working days.

The full meaning of IRB is Institutional Review Board, while the full meaning of FDA is the United States Food and Drugs Administration - a Federal Agency.

The above bodies are responsible for protecting American citizens from harmful products.

Learn more about FDA and IRB at;
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