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Home
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Biomedical Engineering
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Medical Device Design MCQ
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FDA 510(k) process requires:
FDA 510(k) process requires:
A. Full clinical trials
B. Premarket notification demonstrating equivalence
C. Device labeling
D. Post-market surveillance
Explanation:
510(k) demonstrates substantial equivalence.
Tags:
Medical Device Design MCQ
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Biomedical Engineering
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