CDRH Accepting GUDID Account Requests for Class 2 Devices Feb. 1

On Feb. 1, labelers of Class 2 devices can begin requesting accounts for the FDA’s Global Unique Device Identification Database.

Requests should be submitted by April, but definitely no later than June, Linda Sigg, associate director of informatics at CDRH’s Office of Surveillance and Biometrics, said during a Jan. 27 FDA webinar.

The timeframe should help labelers meet the Sept. 24 compliance date.

Labelers must include a UDI on device labels and packages — except if an exception or alternative exists — and submit device identification information to the GUDID, according to a final rule issued in 2013.

The FDA is allowing labelers to get GUDID accounts based on UDI compliance dates, which are being phased in by device class, said Chris Diamant, UDI program analyst for CDRH’s Office of Surveillance and Biometrics.

The program took effect 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.

GUDID is designed to make device identification information available for everyone, including patients, caregivers, healthcare providers, hospitals and industry. — Jonathon Shacat