With compliance deadline for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices finished recently, the FDA’s Center for Devices and Radiological Health (CDRH) has summarized the Unique Device Identifier (UDI) compliance date for Class II devices i.e., on September 24, 2016.
Failing to comply with the deadline pertaining to the new labeling and data submissions requirements will give device manufacturers a severe setback. They might get to see their products tagged by the FDA as misbranded. As a result, there could be many financial and legal penalties, and also the risk of misbranded devices that cannot be sold anywhere.
It is widely known that the UDI is expected to facilitate the easy storage, exchange and integration of data and systems between suppliers and providers in order to improve the traceability and security within the supply chain. So that it increases the visibility of data and improves the quality of information that is being furnished in medical device adverse event reports. While approaching such a sophisticated process device manufacturers are expected to practice consistent, harmonized, and error-free data submissions to avoid setbacks. The need of the hour is to be UDI ready without derailing the production. Here we explain how you should approach. Simple and straight, avoid common UDI data errors.
As the FDA’s UDI initiative relies heavily on the quality data to be submitted to the GUDID database, companies must keep a close eye on common errors that go undetected into data records. In such scenarios, device manufacturers shouldn’t miss some of the critical attributes:
- Among 55 required data fields to be filled out by the device labeling organizations, the D-U-N-S Number stands critical. D-U-N-S, contains nine digits and is to be associated with the company name and address printed on the device label itself.
- UDI hastwo parts; a Device Identifier, (DI) submitted to the GUDID and can be up to 23 characters long, and a Production Identifier (PI). Approved DI Issuing Agency-GS1, HIBCC, and ICCBBA each have different data formats and check digit rules, and submitted data is not same as the human readable or bar code values printed on the product label.
- The Primary and Package DIs must be entered correctly in their respective fields and that Package DIs must not be mistakenly associated with an incorrect Primary DI record.
- Size information must be entered in the Clinically Relevant Size section and use the size list of values where possible, in place of the size text field.
- Enter the device version or model values and remember to omit the word “Version” or “Model.”
There are many such attributes device manufacturers should keep a close watch on while submitting data to GUDID. But as the deadline is fast approaching it is probable that they could be missed / skipped. To streamline your GUDID data submissions absolutely error-free and accurate, Freyr offers the best of both worlds – on-demand UDI software solution, Freyr IDENTITY, as well as a Centre of Excellence (CoE) that offers best in class, cost-effective and customizable UDI services built around your unique and demanding requirements. Fool-proof your GUDID submissions.