The U.S. Food and Drug Administration (FDA) extended the Global Unique Device Identification Database (GUDID) submission compliance date for all labelers required to submit data to the GUDID by September 24, 2015 to October 24, 2015. The extension is the result of GUDID security vulnerability issues that have caused FDA to temporarily take the GUDID offline. Those affected by this extension include:
- Labelers of class II, class I, and undefined implantable, life-supporting, and life-sustaining devices
- Labelers of contact and intraocular lenses
The one-month extension applies only to GUDID data submissions. Affected devices and their packaging must still be labeled with a Unique Device Identifier (UDI) by September 24, 2015. See Registrar Corp’s recently published guide to complying with FDA UDI requirements for more information.
Registrar Corp can help medical device labelers navigate FDA’s UDI and GUDID requirements. Our Regulatory Specialists can help device labelers determine the UDI compliance dates for their specific device, as well as submit their device data to the GUDID. To have Registrar Corp submit your data to FDA’s GUDID, contact us and we will send you a simple spreadsheet to complete and return to us.
For more information on FDA UDI and GUDID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.
