Multi-Part Device Labeling, Other Issues Dog UDI Rule

The FDA’s unique device identification (UDI) rule might improve device tracking but is plagued with unresolved issues such as how to label devices with multiple components.

“I think at 20,000 feet, the rule is very good in terms of providing structure to a large extent, but also some flexibility in implementation,” Jay Crowley, vice president of UDI Services and Solutions at USDM Life Sciences, said. But he added that several interpretation and implantation problems are giving manufacturers headaches.

For example, he said there has been some confusion about who is actually responsible for UDI – i.e., which entity is the labeler. That issue “causes a lot of angst” because the proper way to identify labelers has not transferred from pharmaceutical regulations as expected, he said. — Jeff Kinney