CDRH Industry: Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff

A guidance has been posted titled, “Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff.”

On September 24, 2013, FDA issued regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices (78 FR 58786) (the UDI Rule). FDA established a set of compliance dates, by device classification, for compliance with required labeling and data submission to the Global Unique Device Identification Database (GUDID) under the UDI Rule. For class III devices and devices licensed under the Public Health Service Act, the compliance date was September 24, 2014. FDA granted requests for extensions to the compliance date some of which expire on September 24, 2015. For implantable, life sustaining and life supporting devices (other than class III devices which had a compliance date of September 24, 2014), the compliance date is September 24, 2015.

On August 7, 2015, due to a security vulnerability in GUDID, FDA decided to take the system offline until a patch is implemented. Due to the temporary unavailability of the GUDID system, we intend to exercise enforcement discretion to extend the September 24, 2015, GUDID submission compliance date for the implantable, life-supporting and life-sustaining medical devices to October 24, 2015. For extensions granted to class III labelers that expire between August 7 and September 24, 2015, we also intend to exercise enforcement discretion to extend the expiration date of these extensions to October 24, 2015.

To view the Guidance, please see:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM458634.pdf.”