The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”).
Which company qualifies as the device labeler?
The next question to ask is which company (or companies) involved in bringing a particular device to market qualifies as the device labeler. Is it the manufacturer or the distributor? What about companies involved in contract manufacturing operations or reprocessing multiple use devices? Depending on the process through which the device eventually reaches the market, the question can be confusing.
You can read the FDA’s complete definition of a device labeler in the Final Rule but, in short, the labeler is the entity identified on the device label itself. This is most often, but not always, the manufacturer. The regulatory or compliance team within an organization is typically tasked with examining the FDA’s definition and making this determination.
When two or more companies appear on the label (e.g., “manufactured by Company X, distributed by Company Y”), the responsibility for submission to the GUDID must be agreed upon and should be formalized in the written agreement governing the relationship between these entities. Neglecting the responsibility to submit will likely result in both organizations being held accountable by the FDA. Duplicate submissions should also be avoided, so cooperation on this front between partner companies is essential.
Remember, if your company qualifies as a device labeler, your organization will be held accountable by the FDA for the timely and accurate submission of your product data to the GUDID. The consequences of noncompliance with the UDI mandate can be severe.
If you are unsure of whether your company bears responsibility as the labeler for a device on the U.S. market, please contact us and we will be happy to help you. Time is short for Class II labelers, with fewer than 80 working days before the September 24 deadline.
Reed Tech is a provider of GUDID submission solutions, offering a SaaS UDI tool, as well as fully outsourced submission services. The Reed Tech team has over 10 years of experience helping Life Sciences companies meet FDA submission mandates with an emphasis on data accuracy and customer service.