A labeler is identified by the FDA as any entity that causes a label to be attached to a product to commercially sell the device without any subsequent substitution or alteration of the label.
An individual who causes the label of a product to be replaced or altered to sell the device commercially without any resultant modification or alteration of the label, such that the insertion of the name and contact information to the person selling the device, without any further alteration of the label, does not constitute an alteration to decide if an individual is a labeler.
Typically, the labeler is also the brand owner. It does not actually make the labeler a distributor who attaches their contact details to the label. When a distributor sells a product under its name, the mark can be the labeler. If the manufacturer is not the owner of the brand, the manufacturer does not become the labeler.
Any questions regarding the Unique Device Identifier (UDI) Labeler Responsibilities, please get in touch with us.
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