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DEVICE RAC EXAM 2024 |
Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action?
B. CBER
C. CDRH
D. OCP - ✔✔C
A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
A. CDER