FDA Offers Pointers for Labelers on Submitting Data for GUDID

While Sept. 24 might seem far off, the FDA is urging labelers not to be complacent in meeting that target date for submitting necessary information into the Global Unique Device Identification Database.

That message came loud and clear in a March 10 workshop put on by the agency on UDI deadlines. During the workshop, presenters noted that device identification information can be submitted manually via the GUDID web interface or as XML files using the HL7 SPL method.

Each option has its advantages, noted Indira Konduri, GUDID program manager. The web interface is easy to use and is suitable for smaller companies that don’t have large volumes of records. SPL is better if a company has thousands of submissions; however, that process is more resource intensive and requires more upfront time.

The FDA is allowing labelers to get a GUDID account based on UDI compliance dates, which are being phased in by device class. The program took effect in September 2014 for Class 3 devices, and last September for implantable, life-supporting and life-sustaining devices. The compliance date for Class 1 devices is in 2018 (IDDM, Jan. 29).

The GUDID database requires UDI-related data, including elements associated with the device label, packaging, lot, serial number and expiration date, said Mohan Ponnudurai, director at Sparta Systems.

Ponnudurai added that companies should look now for an automated way to gather these data elements for higher classification devices to get ahead and iron out any issues before the deadline for Class 1 submissions.

“When the EU brings [its] version of UDI, companies will be much more prepared technically and operationally to manage these processes effectively,” he told IDDM. — Jonathon Shacat