FDA Proposes Accelerated Timeline for UDI Rule

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA)  has released an amendment that seeks to move up the deadlines for establishing a unique device identification (UDI) system for certain medical devices.
 
Specifically, the amendment would apply to implantable, life-supporting and life-sustaining devices. The amendment would mean that such devices in the Class III or high-risk category would need a UDI marking one year earlier than first proposed. Implantable devices in the Class II or moderate-risk category would need a UDI marking three years earlier than first proposed. The UDI on the label and device package would be required one year earlier. Implantable devices in the Class I or low-risk category would need the UDI marking five years earlier than first proposed, with the label and device package requirement one year earlier than first proposed.

The FDA is accepting public comments on the proposed change to the UDI timeline until Dec. 19. To read further from AAMI about the public comment process, CLICK HERE.