With the UDI final rule passed and implemented, many companies are still unfamiliar with the UDI requirements. This is a difficult and arduous process that takes a dedicated team and lots of planning. However, compliance can be achieved by starting off on the right foot. Here is a short list of how to get started.
1. Gather a list of your products.
The most important step is gathering a list of your FDA product codes. UDI compliance, at least for 2015, is driven by the FDA assigned pro-code. Simply creating a spreadsheet that gathers your cleared medical devices and any accessories is a great first step.
2. Who is the labeler?
Do you label? Do you use a contract manufacturer? Do you private label? These are all important questions to ask and address during the planning process. You might need to have discussions with the companies you private label for to determine whether they also are prepared for UDI.
3. Have you signed up for a GUDID account?
This can be found on the FDA website. You’ll need to gather some information to be able to request a GUDID account. Most importantly, do you have a DUNS number? This is required to complete an account request. Also, your DUNS number address on the D&B website must be the same as the address in the establishment registration (FURLS) database.
4. What is your current company plan?
UDI compliance not only brings about changes in labeling , but also within the company structure and documentation process. Establishing a master data management plan is critical to UDI compliance because of all the necessary data elements that are entered in the GUDID. SOPs will need to be changed and updated, verification and validation of bar codes, supplier approvals are just a few of the changes to be made to your quality systems.
Compliance is not cheap. The sheer number of hours dedicated to compliance can be significant. For example, the UDI approved agencies charge a one-time fee as well a yearly licensing fee for the barcodes. Is this cost accounted for in a budget?
How can ProMedic help?
We provide our clients with a turn-key approach to UDI compliance. ProMedic has strategic partners to aid your company in any aspect of UDI compliance. Please contact us today if you need help.