Potential UDI System Draws Industry Comment

Devicemakers, industry associations, policymakers and other stakeholders presented their concerns at an FDA public workshop last month to help the agency better understand the issues involved in establishing a unique device identification (UDI) system.

The system, which could include bar codes and radio-frequency identifiers, is expected to facilitate device recalls and help detect early warning signs of defective devices.

However, several questions — such as what types of devices should be subject to the requirements, how a UDI should be presented and how a database should be developed — have delayed the creation of a system.
The GMP Letter