Do you know the catalog number, product code and package quantity for every version of every medical device in your product portfolio? What about the dimensions (down to the millimeter), the serial number, or the best contact person’s email address?
Of course, most employees of medical device companies do not know that information off the top of their heads but, if they needed to, they could find it. Now, as device labelers seek to comply with the FDA’s final rule on UDI, they need to.
Planning, executing, and supervising data collection and management is a significant part of any UDI compliance program. Class III labelers have already learned how challenging these tasks can be since they were required to collect the data and then submit their device records to the FDA in 2014. Those records are now included in the GUDID, the FDA’s UDI database.
Now, Class II labelers face a UDI compliance deadline of Sept. 24, 2016 (2015 for Implantable, Life-Supporting, or Life-Sustaining Class IIs), and are applying the lessons learned from the earliest GUDID submissions to their own processes. Chief among the recommendations heard from Class III labelers by Reed Tech staff is to start early evaluating the way your company currently stores the data for each unique medical device in order to bring that information together into one central data record.
Each UDI record contains 55 data fields which must be submitted by the device labeler. Each record requires data to be pulled from various business divisions, from labeling and regulatory to production and packaging.
For small companies making just a handful of devices, that may not be particularly challenging. The leaders of those business divisions may work under the same roof and be able to sit down together to collect the required data into a simple spreadsheet.
Unfortunately, most Class II labelers have to navigate a more difficult process. Class II contains the greatest number of devices and most manufacturers make hundreds if not thousands or tens of thousands of unique devices. Many companies have facilities in several states or even in different countries and some may have subsidiaries making products under their own labels.
How do you collect these 55 data points for tens of thousands of devices across multiple business divisions and be sure each field is correct, up-to-date, and ready to submit to the FDA? That is the challenge Class II manufacturers face. To plan your approach to UDI data collection, a suggested outline is shown below:
- Assess product volume: How many products in your portfolio fall into each class? What is the UDI compliance deadline for each class of device in your portfolio?
- Map affected business units: Which internal divisions are the keepers of the required data? Which divisions need to support the UDI compliance program?
- Inventory data fields: Review each of the 55 data fields required for submission. What business operating unit is the primary keeper of that data? Do any fields require data from external suppliers or partners?
- Evaluate current data storage: How is the data stored within each division? How easily can those sources of data be merged together into one cohesive system?
Remember, if this seems overwhelming, help is available. Reed Tech experts can help you develop a plan for compliance with the FDA’s UDI data submission mandate and guide you through the process to a compliant UDI data record submission.