The rule defines a “labeler” as:
- Any person who causes a label to be applied to a device with the intent that the device will be
commercially distributed without any intended subsequent replacement or modification of the label; - Any person who causes the label of a device to be replaced or modified with the intent that the
device will be commercially distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information for, a person who distributes
the device, without making any other changes to the label, is not a modification for the purposes of
determining whether a person is a labeler.
According to the rule, labelers include manufacturers, reprocessors, specification developers, repackagers
and relabelers that cause a label to be applied to a medical device.
