Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

July 17, 2017 Daniel Henrich

Class_One_DevicesAs you probably know by now, FDA recently announced it would extend the Class I UDI compliance date for labeling and GUDID submissions by two years to September 24, 2020. In this post, we will take a look at why FDA chose to take this step and how Class I labelers should view their extended timeline for UDI compliance.

 

Data Quality at the Forefront

At the annual UDI Conference in Baltimore last month, FDA representatives emphasized that the agency is increasingly focused on data quality--“It costs about one dollar to verify a record as it’s being entered in the system, ten times as much to correct it and one hundred times as much to not correct it.” With more than 1.4 million records currently in GUDID, the costs of bad data are beginning to add up.   

By extending the Class I deadline, FDA is creating some breathing room for its staff to review existing GUDID records for accuracy and institute new validation measures and editing rules. But FDA is also providing each Class I labeler with the chance to align required data and focus on data quality.

The lesson learned from the UDI compliance program so far is that, on the whole, industry’s data collection and submission efforts have not provided good enough data for the desired downstream applications of UDI. FDA’s UDI data quality initiative suggests the agency will be raising the bar on data quality expectations for Class I labelers. With an extended deadline, industry will have no excuse for not providing accurate data records.  

Lessons from Class III and II Compliance Efforts

Class III and II labelers learned that the UDI data collection effort is not a simple task of populating  a spreadsheet by circulating it to different departments. It turns out that there is confusion in many organizations about which data values are correct and identifying a single source of truth is not always possible. Your company’s data is likely in a different format from what FDA requires. Or you may find the agency is asking for some data that your organization has never recorded before. In that case, it will take a significant effort to record and carefully review those data values for each device record.

Data Demands Beyond FDA: Trading Partners

Keep in mind, just because the FDA deadline for submitting Class I product data electronically is now 2020 does not mean that other trading partners will wait that long for the data they need. Group Purchasing Organizations (GPOs) and Hospital Networks have already begun demanding product data from suppliers through the Global Data Synchronization Network (GDSN).

In addition, a federal program by the Centers for Medicaid and Medicare Services (CMS) provides incentives for hospitals to demonstrate “meaningful use” of UDI within patient Electronic Health Records (EHRs) beginning in 2017.

Device labelers should expect that demands for their product data (regardless of device class) to be made available through GUDID and GDSN will continue to build.

Members of our Reed Tech team have spoken to many industry members who see the Class I extension as some extra cushion in case of unforeseen obstacles, but they plan to continue their Class I compliance programs with a goal of submission to GUDID in 2018, regardless of the deadline extension. 

The Need for Product Data Management

Though very high profile, the U.S. UDI program is just one of a growing number of demands by external organizations for device companies to share product data in a structured format. Beyond FDA’s UDI demands, there are the U.K. NHS eProcurement initiative, upcoming UDI requirements in the EU and numerous commercial pressures to provide device product data electronically.

All of this is leading forward-thinking industry members to a central conclusion—the core challenge to meeting these demands is not a matter of data conversion and submission. The challenge is really one of product data management. Device companies need to collect their product data and manage it in a central location. This allows them to establish an indisputable single source of truth for use across the organization. This source can then be leveraged to fulfill current and upcoming demands for that data, regardless of who is asking for it or their formatting requirements.  

In conclusion, when thinking and talking with colleagues about the Class I extension, remember:

  • FDA’s Class I extension is about ensuring GUDID data quality and submission accuracy, not about giving industry time to work on other projects.
  • Industry leaders plan to continue to execute on their existing Class I timelines for compliance in 2018.
  • Just because FDA’s Class I GUDID deadline is now 2020 does not mean other important stakeholders won’t need access to the data sooner.
  • FDA’s UDI program is just one of many use cases for investing in a central device product data repository.

So now is the time to act! Across various industry initiatives from FDA, EU and other organizations, a common theme is clear—the medical device industry’s deadline for patient safety and data accuracy is now.  

Need help understanding UDI or other product data requirements? Unsure of how to begin? Contact the team at Reed Tech. We will be happy to help you put a plan in place.

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