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Domain questions check that you actually use the knowledge, not just that you can recall the textbook. Interviewers want a sharp, specific answer that betrays day-to-day fluency.

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Domain · Technical Depth

Walk me through how you'd decide whether a new device clears the FDA through the 510(k) pathway versus a PMA — and what a De Novo request is for.

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Walk me through how you'd decide whether a new device clears the FDA through the 510(k) pathway versus a PMA — and what a De Novo request is for.

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