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Correction vs. removal vs. market withdrawal

A correction fixes a device in the field; a removal takes it out of the field or market; a market withdrawal is a minor action for a violation FDA wouldn't otherwise act on.

21 CFR Part 806; 21 CFR 7.3
What people get wrong

The category you pick determines your reporting obligation. Corrections and removals that address a risk to health must be reported to FDA under 21 CFR Part 806, typically within 10 working days. A market withdrawal — a minor issue like a labeling typo that isn't a health risk — generally doesn't require an FDA report at all. Misclassifying a real removal as a market withdrawal to avoid reporting is the mistake that turns a routine field action into an enforcement problem.

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