Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification is going to take time and planning. But convincing the executives in the C-suite to allot the necessary time and resources needed to get the job done can sometimes be challenging. When faced with requests from sales and marketing, R&D, manufacturing, and other departments, CEOs understandably have many demands to manage.
Buy-in from the top is critical to implementing your project on time and on budget. Here are the most important things your CEO needs to understand about compliance with the mandate.
It will take longer than we think.
The manufacturers of Implantable, Life-Sustaining, and Life-Supporting (I/LS/LS) devices must comply with the final rule by submitting to the Global Unique Device Identification Database (GUDID) by Sept. 24, 2015. Class II manufacturers have until Sept. 24, 2016. While it is tempting to think there is time to spare, the experience of the Class III manufacturers in 2014 proved that a successful compliance effort can take many months to implement. Starting early leaves room to navigate the obstacles that may arise along the way.
Not complying will cost us money.
Device manufacturers that do not meet the deadline to comply with the new labeling and data submissions requirements run the risk of their products being considered by the FDA as misbranded. Under FDA guidelines, non-compliant labels are treated the same as labels that may contain “false or misleading” information. Apart from the risk of financial and legal penalties, misbranded devices may not be sold.
Departments will have to work together.
At first glance, UDI compliance may have seemed the responsibility only of the regulatory or labeling departments. However, as the full scope of the requirements became known, it became clear that meeting the new regulations requires input from and carries implications for many other departments, including manufacturing, IT, legal, supply chain, and others. In small companies, that might not pose too much of an issue. In medium and large companies, where departments may be in different buildings and perhaps different cities or even countries, coordinating that interaction requires more time and planning.
Data collection may require new processes.
The amount of data required to be submitted to the GUDID is not only substantial, but is typically stored in disparate departments and systems. The product code, for example, may come from Regulatory, while the device count may come from Packaging, and the expiration date may come from Production. When different departments are owners of different types of data, the information is likely to be stored in a variety of formats and locations, from spreadsheets to databases. Compiling all that information into one central repository for GUDID submission may require new ways of doing business.
As medical device manufacturers become more familiar with the requirements for compliance, many find they have to change the way they process information, put new teams in place, purchase new equipment or software, or enlist the help of a third-party expert. Making those decisions will be an easier process if the company’s top leadership understands the context and consequences of those decisions.