Heads-up: Class II Device’s Unique Device Identifier (UDI) Compliance is here. As part of the phased approach to UDIs, the US Food and Drug Authority (FDA) has mandated manufacturers of Class II devices to get complied by Sep 24 2016. The upcoming mandate is succeeding the Class III (Implanted) devices’ compliance in 2015 and preceding the Class I devices’ compliance scheduled in 2018. With just five months away for the Class II device compliance date, FDA has thoroughly discussed the new enhancements to the data elements to be submitted into Global Unique Data Identifier Database (GUDID).
As required as usual, device manufacturers are expected to submit Device Identifiers (DI) to GUDID in order to get compliant by the respective deadlines. A Device Identifier is a unique number assigned on the basis of model or version of the device.
As part of the GUDID enhancements, in a recent development, the FDA has come up with the new data element, i.e. Device Identifier (DI) trigger. The new data element will be a part of GUDID’s data entry which, if changed, the device should obtain a new DI. For e.g., if the manufacturer has earlier submitted an entry confirming that the device is for single use, and later may wish to change it for multi-use, he needs to assign a different DI for the device and will have to submit to GUDID again.
In general, these trigger data elements cannot be edited once published in GUDID. However, making it easy for the device manufacturers, the FDA is giving grace period of 30 days from the first day of publishing, to edit and resubmit without a need to generate a new DI.
Likewise, FDA has come up with a couple of other GUDID enhancements in the last year. To list a few:
- The ability to accept de novo premarket submissions
- The ability to submit package DIs for devices with a single device in a package
- The ability to export all submitted DI records as XML files, rather than being limited to 100 at a time
- Refinements to data accessibility based on different user types
While submitting the device data to GUDID, companies will have to track DI and PI elements accurately. With just a few months away from the Class II Device UDI compliance, the challenge for device manufacturers is to track the required new DI triggers and integrate them without fail. Therefore, it is recommended to choose a specialized global Regulatory partner offering the best of both worlds – on-demand, fully configurable, 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.