UDI Barcoding

RFID - UDI - FDA

23 Sep UDI Barcoding

Unique Device Identifier (UDI) Barcoding
FDA-UDI-INFO

The second stage of compliance for UDI barcoding is on the horizon. On September 24, 2015 all labels and packages of implantable, life-supporting and life sustaining devices must bear a UDI. Are you compliant with new UDI regulations?
A UDI comprises of two parts:

  1. A device identifier (DI) which is a unique alphanumeric or numeric code, that is specific to a device version or model.
  2. A Production Identifier (PI) which is an alphanumeric or numeric code, that identifies the production information for a device and may include the following information:
    • Batch Number
    • Serial Number
    • Expiration Date
    • Date of Manufacture
    • For a human cell, tissue or cellular or tissue-based product (HCT/P) regulated as a device, the distinct identification code that allows the manufacturer to associate the HCT/P to the donor.

The UDI must appear in both plain text format and also in a machine readable format. Below we can examine a fictitious sample medical device label which displays the GUDID elements. In the image below the plain text format can be seen along with a 1D barcode which is required for machine-readable format.

CompuHyper GlobalMed

As part of the UDI system the FDA have introduced a Global Unique Device Identification Database (GUDID) http://accessgudid.nlm.nih.gov/ . The system contains Device Identification information submitted by device companies to the FDA. The GUDID only contains the Device Identifier (DI), which serves as the primary key to obtain information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but GUDID data indicates which Production Identifiers are on the label.

Compliance Date
Requirements
24 September 2014
Class III medical devices and devices licenced under the (PHS Act)
24 September 2015
The labels and packages of implantable, life supporting and life sustaining devices are required to be UDI barcoded.
24 September 2016
Class III devices required to be labelled with a UDI. Must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
24 September 2018
A class II device that is required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.
24 September 2020
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labelled with a UDI, must have a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

For more information contact System Label today to understand how we can assist you with the printing of
UDI Barcodes.