FDA drops UDI compliance need for some low-risk devices

The FDA has updated its guidance on unique device identifier (UDI) requirements for low-risk (class I) and unclassified medical devices considered to be consumer health products, typically sold over-the-counter (OTC) at non-specialty retailers including drug, grocery and convenience stores, as well as online.

The final version of the agency's thinking on the category removes the need for some consumer medical device (CMD) products to comply with some of the UDI requirements altogether, and gives advice on how a manufacturer can determine whether its device is exempt.

It also extends the enforcement discretion period for class I and unclassified devices that are not consumer products and therefore still in scope to December 8 of this year, 75 days later than originally planned, as some manufacturers were waiting for this policy on consumer medical devices.

A legal requirement for the FDA to develop a UDI system was put in place in 2007, when legislation mandated a system to allow identification of medical devices through both use and distribution as an addition to existing labelling requirements.

FDA established a UDI system in 2013 that requires all devices to bear a UDI on labels and packaging unless exempt, with details of the products including a universal product code (UPC) submitted to FDA's Global Unique Device Identification Database (GUDID).

"The UPC is used to identify products to a very granular level – such as where in stores the product is displayed, and whether the product has temporary promotional packaging – and the UPC for the same version or model of a device can change frequently," says the new guidance.

"With respect to class I devices that are consumer health products, FDA believes that the entry of UDI data into GUDID, especially given the frequent changes to the UPCs serving as the UDIs for these devices, is burdensome to stakeholders," it adds.

CMDs encompass a wide range of devices, including oral and feminine care and sexual health devices, first aid devices, and adult incontinence goods.