Nobody knows a medical device manufacturer’s products better than the manufacturer itself. However, there are a number of good reasons why a manufacturer working to comply with the FDA’s final rule on Unique Device Identification may want to consider bringing in outside help.
1. You got a late start. The dual challenges of labeling changes and GUDID submissions are formidable enough. If you are facing acute deadline pressure, calling in an expert can be the difference between a successful project and a stressful, rushed experience for you and your staff that culminates in missed deadlines.
2. An outside firm already has UDI compliance experience. A credible UDI solutions vendor has been through the process already, having helped Class III device manufacturers to meet the first compliance deadline in 2014. A company that outsources its UDI needs now can benefit from the lessons learned during that experience.
3. You have limited staff resources. Device companies come in all shapes and sizes. A company with a few dozen employees or a small compliance group may require outside help. A UDI solutions vendor often can provide turnkey compliance solutions to these organizations.
4. Good data is vital. Data validation is a crucial, labor-intensive part of the new reality of a UDI compliance workflow. The initial data collection, especially when the workflow is new, will very likely contain errors. The last thing a device manufacturer wants to do is send bad data to FDA. If the time-consuming task of data validation falls to you and your staff, it likely will demand time and resources you do not have while also introducing additional opportunities for human error. Outsourcing UDI compliance enables medical device manufacturers to capitalize on proven validation infrastructure and procedures that have already been put into place for previous GUDID submission projects.
5. A third party can organize UDI efforts. UDI compliance at a global company with dozens of locations requires central coordination that may be difficult to marshal internally. The data that eventually populates the completed GUDID record may be collected from widely disparate parts of an organization. It is likely that some of these divisions rarely worked closely together until UDI compliance efforts began. GUDID data collection, then, may require the coordination of data that arrives at different times, in different formats, and from different operational environments. With backing from senior management, an experienced UDI solution vendor will be able to transcend operational and logistical barriers within large organizations that could frustrate internal groups.
Regardless of the reasons a medical device company may opt to outsource its UDI compliance project, it is important to remember that it is the device labeler who will ultimately be responsible to FDA. Select a UDI submissions partner who can help you get it right the first time.