2024 DEVICE Clinical Analysis RAC Exam With Answers (187 Solved Questions)

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DEVICE RAC EXAM2024|Questionswith 100%Correct Answers | Verified | Latest Update 2024|Graded A+Which division would have primary jurisdiction over a vascular graft with anantibiotic based on primary mode of action?A. CDERB. CBERC. CDRHD. OCP-✔✔CA company wants to modify its legally marketed device such that the modificationdoes not affect the intended use or alter the fundamental scientific technology ofthe device. If the design outputs of the modified device meet the design inputrequirements,this change would be best filed as a(n):A. Special 510(k)B. Abbreviated 510(k)C. Traditional 510(k)

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