Correction

Under 21 CFR 806, corrections done to reduce a risk to health or fix a violation must be reported to FDA. Telling a correction apart from a device enhancement is a question that comes up often.

Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

21 CFR, 806.2

Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

21 CFR, 7.3

21 CFR 7.3 covers products generally and says without physical removal to some other location. 21 CFR 806.2 covers devices and adds from its point of use.