So i have read CFR 806.10 and everything is tied to
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).
The mislabeling we have poses no risk. Since this labeling error does not meet the requirements of 1 or 2 above would we need to notify the FDA?
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).
The mislabeling we have poses no risk. Since this labeling error does not meet the requirements of 1 or 2 above would we need to notify the FDA?