On Nov. 19, 2012, the FDA announced an amendment to its July 10, 2012, proposed rule for a Unique Device Identification (UDI) system. Comments on the amendment to the proposed rule are due by Dec. 19, 2012. The FDA explained that the amendments were necessary to comply with the Food and Drug Administration Safety and Innovation Act (FDASI) passed in July 2012. The amendments to the proposed rule shorten the compliance deadline for certain UDI requirements. The key changes are:

  1. All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device within two years after publication of the final rule. The time difference than originally proposed for each class of device is:
  • Class III devices: one year earlier
  • Class II devices: three years earlier
  • Class I devices: five years earlier
  1. The label and package of implantable, life-supporting and life-sustaining Class II and Class I devices must bear a UDI within two years after publication of the final rule. The time difference than originally proposed for each class of device is:
  • Class II devices: one year earlier
  • Class I devices: three years earlier

The industry has already pushed back against the originally proposed UDI direct marking requirements for implantable devices, stating that the requirements present enormous technical challenges and will cost billions of dollars. Although most implantable devices are Class III devices, this amendment will speed up the direct marking requirements for Class II and Class I implantable devices.

See our previous alert, “November 7 Comment Deadline for FDA’s Unique Device Identification Rules: Three Key Points,” for more on this topic.