UDI Requirements for Combo Products Guide

FDA has posted a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Products.” The document discusses how the agency’s UDI requirements apply to combination products with device constituent parts. It also outlines requirements, recommendations, and best practices for UDI labeling and submission of information to the Global Unique Device Identification Database (GUDID) for such combination products. Hypothetical examples are also included to illustrate how UDI requirements can be met for such products.

According to the guidance, a combination product may not be subject to UDI requirements if all of the device constituent parts are considered Class 1 devices. Additionally, if the device constituent part of a combination product is an investigational device, then the investigational combination product is not subject to UDI requirements, it adds.