All Class II devices marketed in the USA must be labeled with UDI bar codes by September 24, 2016–just 19 days away. This announcement summarizes the basic steps for UDI implementation.

Step 1: Make a list of all the devices requiring a UDI. A separate UDI is needed for each size and packaging configuration. For example, if you sell sterile syringes individually, ten per box and 100 per case–then you need three different UDI for each size of syringe you sell.

Step 2: Apply for a block of device identifiers (DIs) from GS1 (http://www.gs1.org/) or a single labeler identification code (LIC) from HIBCC (http://www.hibcc.org/). GS1 sells blocks of DIs in quantities of 10, 100, 1000, etc.; while HIBCC sells a single LIC. GS1 blocks of DIs are generally less expensive than a single LIC, but there are also maintenance charges. Therefore, HIBCC is typically less expensive in the long run for companies. For a small company these charges are approximately $1,000 (order of magnitude estimate).

Step 3: Assign DIs to each of your devices from step 1. There are 55 attributes for each DI provided in the upload to the FDA GUDID. Most UDI consultants will be able to provide a sample procedure to manage this process and a form for approving the attribute data for each new DI. You can do this yourself with an Excel spreadsheet template, but use the free FDA GUDID elements reference table as a starting point for creating your own form:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396592.xls

Step 4: Request a GUDID account from the FDA. The FDA responds to requests in a few days and you will have full account access in about a week. The following webpage provides information for requesting access:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416113.htm

Step 5: Create sample UDIs for each device assigned a DI. You need software to generate a bar code in the required UDI format and then the code is inserted into your label template for each lot. Serialized products need software that generates a series of serialized bar codes. You can manually review and approve each sample UDI and the final label, but you must verify that the bar code is machine readable (i.e., automatic identification and data capture (AIDC) technology). This process is required for each device before you upload the information to the GUDID.

Step 6: Enter GUDID elements for each device into the FDA GUDID. This can be done manually and verified for accuracy, or it can be done automatically with a validated software system. Reed Tech (http://www.reedtech.com/products-services/life-sciences/medical-device-udi-management) offers software designed for small and mid-size medical device manufacturers to automatically upload all of the data elements.

If you have 10 devices in total, this process can be implemented manually in a few weeks. If you have closer to 100 devices, you will probably need more time to complete the implementation. Prioritize your highest volume products first. Although the compliance deadline is September 24, there is a grace period of three years for existing inventory. Any inventory labeled prior to September 24, does not need to be relabeled if it is distributed within that three year period.

If you have more than 100 different devices, then you may find that you need an automated system to help you generate UDI bar codes and maintain information for the FDA GUDID. UDI implementation may be your reason for upgrading to a new MRP software system or implementation of on-demand printing. Automation projects require longer to implement in order to populate the software database, validate the software and train personnel. You may need to implement UDI labeling in parallel with planning and implementation of an automated system.

source: https://www.linkedin.com/groups/2070960/2070960-6178555579401793536