Critical: FDA Issues Initial UDI Database Guidance
Tuesday, June 10, 2014
The following communication was received from the FDA regarding implementation of the Unique Device Identification system. Manufacturers and suppliers should take note of the following information as the deadline nears for compliance to the UDI rule.
While the second phase is being finalized, the draft GUDID guidance
will continue to be available on the FDA website so that you can continue to access the sections that are not finalized.
The GUDID is one of two core elements outlined in the Unique Device Identification System final rule
, published on September 24, 2013. (The other element is the requirement to place a unique device identifier on device labels and packages). The purpose of the GUDID is to act as an information resource on medical devices that have a unique device identifier.
The first phase of the guidance updates information we've identified through discussions with industry as being critical to immediately establish and use GUDID accounts. This includes sections on establishing and using a GUDID account, the unique device identifier, Global Medical Device Nomenclature (GMDN), and electronic records/electronic signatures. Also included in this phase are GUDID attributes mapped to a fictitious medical device label and a glossary.
In addition, two components of the draft GUDID Guidance-Appendices B and C
-have been removed from the guidance and posted separately on the FDA UDI website. These files contain technical specifications, regarding GUDID data elements and UDI formats by accredited issuing agencies, that do not describe the agency's interpretation of or policy on a regulatory issue, and the FDA will not publish them as part of the GUDID guidance.
As the September 24, 2014
UDI compliance date for class III devices and devices licensed under the Public Health Service Act approaches, we highly encourage labelers of these devices to use this first phase of the GUDID guidance to establish accounts and begin submitting data to the GUDID. The FDA's most immediate priority is assisting companies in meeting their UDI requirements, including submitting data to the GUDID, in a timely and successful manner. To that end, we encourage you to send your questions about UDI implementation to the FDA's UDI Help Desk
Thank you for your continued support of this important program and we look forward to working with you in the future.
Food and Drug Administration
Center for Devices and Radiological Health