FDA Proposes Accelerated Timeline for UDI Rule
The U.S. Food and Drug Administration 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 says the new deadlines are needed to comply with the Food and Drug Administration Safety and Innovation Act, which was signed into law on July 9, 2012. The FDA had released its long-awaited proposed UDI rule earlier that month. Under the proposed UDI rule, manufacturers would be required to place a numeric or alphanumeric code on most medical devices. That label would include such information as the serial number and expiration date for the device. Supporters of the UDI system say it will enhance patient safety through better tracking of medical devices, and that will allow healthcare facilities, manufacturers, and regulators and to react more quickly to adverse events or recalls.
Manufacturers have generally supported the proposed UDI system, but have also raised concerns about the cost and how it would be implemented. Even before the FDA released the amendment to change the timeframe, they had questioned how quickly it could be adopted.
The FDA is accepting public comments on the proposed change to the UDI timeline until Dec. 19. For information on how to submit comments and to read the proposed amendment as published in the Federal Register, click here.
Posted: November 21, 2012