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A Brief Look at the Unique Device Identifier (UDI) Labeler Responsibilities

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.

Also…

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.

UReg FDA Registrations is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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