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Interviewers ask this kind of question to surface how you think, not what you remember. The strongest answers are specific, calmly told, and end on what changed.

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Judgment & ambiguity · Calibrating confidence

A design change to a cleared device could be handled as a letter-to-file or could require a new 510(k) — the 'could this significantly affect safety or effectiveness' judgment is genuinely borderline. How sure are you, and how do you make the call defensible?

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A design change to a cleared device could be handled as a letter-to-file or could require a new 510(k) — the 'could this significantly affect safety or effectiveness' judgment is genuinely borderline. How sure are you, and how do you make the call defensible?

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