As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data record for the devices they market in the United States to the FDA’s Global Unique Device Identifier Database (GUDID).

But who does the FDA consider to be the labeler? Is it the device specification developer, or perhaps the manufacturer? What about the device distributor, reprocessor, repackager, or relabler?

You can read the full definition of a labeler in the UDI Final Rule. However, the short answer to the question is that the labeler is the entity that applies or modifies the label and then brings the device to market under its brand. In most cases, this is the device manufacturer, but it could also be one of the other entities mentioned above. Typically, a medical device company will task its regulatory or compliance team with determining whether it is, in fact, the labeler according to the FDA’s definition.

If multiple parties are involved in bringing a product to market, the labeler responsible for the submission should be defined in the agreement governing the joint venture.

Remember, if you are the labeler – as defined above –  you are required to submit and maintain the UDI data record.

If you have questions about your company’s status as the labeler of a product or other issues related to GUDID submission, please contact the experts at Reed Tech. We will be happy to assist you.