Q1: What is the GUDID?
RK: The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the U.S. Food and Drug Administration (US FDA) that serves as a reference catalog for every device with an identifier. Identifiers are intended to support post-market activities such as reporting, monitoring, analyzing adverse event reports, and recalls. The GUDID is also intended to help monitor devices globally, which aids patient safety and efforts to prevent and combat the counterfeiting of medical devices.
Under the final rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative. It is part of a larger UDI final ruling that was put into effect in September 2013 and includes new and clarified requirements for UDI labeling and direct marking on specific devices.
Q2: What changes are coming and why are they being implemented?
RK: On September 24, 2013, the US FDA issued a final rule that established the need for the UDI System. Soon after the UDI System was signed into law as part of the Food and Drug Administration Amendments Act of 2007, the FDA was called to publish a timeline for the UDI implementation (included at the end of the interview). The UDI law is being introduced based on device risk classification with the highest risk (Class III) devices required to comply by September 24, 2014 and the lowest risk devices by September 24, 2020 (leaving room for a seven-year introduction).
Q3: Who will the changes apply to and when will they take effect?
RK: Before September 24, 2015 (two years after Issuance of Final Rule UDI), all Class II life-sustaining & life supporting and implantable devices must conform to UDI labeling requirements and be entered into the GUDID. For devices that are designed to be used more than once and/or require processing before every reuse, a permanent UDI marking on the devices themselves is required. UDI must be provided by Class III stand-alone software that is life-sustaining or life-supporting. It is recommended that all manufacturers who are unsure whether or not their devices, reusable devices, or software devices meet these definitions should plan to comply voluntarily since the US FDA is allowing GUDID entry for all Class II devices at this time.
Q4: How can manufacturers prepare for the changes/new requirements?
RK: This rule applies to labelers, which may be device manufacturer, specification developer, single-use device reprocessor, convenience kit assembler, repackager, or relabeler. Manufacturers will require a GUDID account, a DUNS number, and a GS1 account for each of their labelers. Manufacturers may then determine the UDI requirements for each label. The information from each label may be captured in a spreadsheet for easy reference and that spreadsheet may be used to populate the GUDID for each label. The process is time consuming and may be a little confusing for some organizations. In response, we are offering a new service to assist in the creation of the labeler’s GUDID account through our own third party submitter account. From that point, Arazy Group may enter and maintain all GUDID entries, audit UDI labeling, and ensure direct markings are in compliance (where applicable) for you.
Q5: What additional recommendations do you have for manufacturers for efficient submissions?
RK: Labelers should familiarize themselves with the FDA GUDID and UDI guidance available in the public domain and should contact Arazy Group for assistance with compliance as needed. All labelers will be required to comply, even those not required to comply by September 24, 2015.
More information on the UDI and GUDID programs from the US FDA can be found here.
During 2014, Arazy Group gained significant experience ensuring successful compliance with UDI and GUDID for all our Class III clients. If you have Class II devices (identified specifically at the end of this article), you must ensure compliance by September 24 2015.