As China and the European Union prepare to issue their own unique device identifier regulations by the end of the year, devicemakers should develop a design flexible enough to allow for use outside the U.S. with modest revisions, the FDA’s former chief UDI architect says.
Jay Crowley, vice president and UDI practice lead at USDM Life Sciences, explains that the Chinese and EU regulations will differ slightly in details such as registration numbers, so a label that can be easily modified will be beneficial. Crowley spoke at an FDAnews webinar.
Crowley reminds devicemakers that their products already have stock keeping unit, or SKU, codes, so this is a good place to start when focusing on UDI labels. He suggests having each SKU line up with a single UDI, with the UDIs changing when SKUs do and vice versa.
SKUs can help in assembling a list of products subject to UDI, Crowley says. Frequently, companies discover that they don’t have good internal data on how products are packaged or labeled, or occasionally even whether the device was FDA-approved or reached the market through some other means.
Besides SKUs, devicemakers may need to refer to UDI guidance to confirm whether a specific device is considered an accessory subject to the tracking rule, Crowley says. He encourages companies to write SOPs defining how they determine if a product is an accessory, a stand-alone device or something else.
When it comes to registering the UDI and listing it in the Global UDI Database, companies should name one party to serve as labeler, Crowley says. This is particularly useful if the device is manufactured and labeled by several different companies or in several different locations, or if contract manufacturers are involved, he adds.
Devicemakers should also use the “own name” rule of thumb, Crowley says. If a device is distributed under your brand name, you’re probably the labeler even if you don’t physically get the product to market.
By the end of 2015, Class III devices, Class II implants and devices that are life-supporting or life-sustaining will have to carry UDIs. Identifiers for the remainder of Class II devices are due next year, followed by Class I devices in 2018. — Elizabeth Orr