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Class II UDI compliance: Accuracy required

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The Sept. 24, 2016, deadline for Class II Unique Device Identification (UDI) submissions requires not just that your system for sending your data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that system be complete and accurate.

Our 2014 survey of Class III device manufacturers found that 80 percent believed that accuracy of the final GUDID submission was the most important attribute of any GUDID solution.

In order to meet a high level of data accuracy, labelers must rely on subject matter expertise and must spend significant time reviewing the FDA’s guidance as well as their own data. Locating and gathering data from across your company is one challenge. Transforming it into formats required by the FDA’s final rule is another. The GUDID solution you choose for that data transformation is critical.

Manufacturers should carefully review each product that must be submitted to the GUDID. Over a dozen of the FDA’s GUDID attributes are conditionally required and may or may not be needed for the submission. Labelers of repurposed or reprocessed devices must submit information regarding the Direct Marking Device Identifier, while this information is not needed for single use devices.

A thorough review of the acceptable values for GUDID submission is mandatory. As labelers of previous class submissions began locating the data attributes necessary for submission, many found their data did not adequately conform to FDA’s controlled vocabulary standards. One such example is the MRI Safety Status attribute. FDA prescribes four controlled vocabulary terms for this field: MR Conditional, MR Safe, MR Unsafe or Labeling does not contain MRI Safety Information.



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Many device labelers discovered this information was not readily available within their internal databases. Significant time was needed to review internal documentation in order to find this single data attribute. Additionally, labelers learned it was necessary to create a master data repository in order to archive this data for record maintenance and future use.

Labelers should also consider data that currently exists in internal data repositories but may not adequately meet FDA’s controlled vocabulary standards. For example, a device manufacturer may use the value “centimeter” in an internal database, while the FDA requires the value “cm” be submitted to the GUDID. This may result in weeks of manual review time or significant IT costs in order to make the necessary transformations.

With these challenges in mind, Reed Tech developed a GUDID submission solution with a number of features designed to increase accuracy and reduce the risk of failed submissions.

The features include built-in data verification routines that alert our clients if their data contains information that is non-compliant. Our system flags the data with error messages so it can be corrected before submission to the FDA.

Additionally, the Reed Tech GUDID Solution can also perform a number of controlled vocabulary transformations. That means that a device manufacturer can supply one of nine different date formats to Reed Tech and our system will catch the discrepancy and, if appropriate, transform the data attribute to make sure the SPL submission passes the formatting requirements of the FDA.

Reed Tech customers get the advantage of our built-in data verification measures and also benefit from the knowledge and experience of our in-house subject matter experts. Customers contact our experts for assistance in creating, organizing, and managing GUDID data attributes, as well as help handling the complex technical requirements of the UDI rule.

To learn more about how Reed Tech’s UDI compliance solution can help you get started and ensure accurate compliance in a timely manner, contact us today.