Device Labeler

Definition 1

An individual that labels a device. (NCI Thesaurus)

Definition 2

Any person who causes a label to be applied to a device with the intent that the device will be introduced into interstate commerce without any intended subsequent replacement or modification of the label; and any person who causes the label of a device to be modified with the intent that the device will be introduced into interstate commerce 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. Per 21 CFR 801.3. (Food and Drug Administration)

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