An FDA workshop is being held on Feb. 12 to gain input regarding development of unique device identifiers (UDIs) for medical devices. Systems under review use bar codes and radiofrequency identifiers.

The FDA Amendments Act of 2007 mandated development of such a system without including a firm deadline. The Act requires a unique identifier to “adequately identify the device through distribution and use.” Following the February workshop, FDA plans to begin drafting regulations to implement the requirements of the Act.

The agency has identified a number of questions for which it seeks input through the workshop. For example:

• What types of devices should be subject to the requirements of a UDI system? Which should be exempted?

• What should be the UDI’s components? For example, should it require the lot or serial number?

• Where should the UDI be placed? What criteria would guide an alternative location?

• What identification technology would be appropriate? Should FDA mandate a particular technology or permit use of different standards depending on the type of device?

• How should the UDI database be developed and maintained?

For more information or to register, click here.