GLOSSARYUS
Correction and Removal
Two actions a manufacturer takes on a device already distributed. A correction acts on the device where it is used, such as a repair in the field. A removal takes the device from its point of use to another location for actions such as repair, relabeling, or destruction.
Avoid This Mistake
The duty to report does not wait for the FDA to call an action a recall. A manufacturer that starts a correction or removal to reduce a risk to health must report within 10 working days, unless an exemption in 21 CFR 806.1(b) applies.