What is GUDID?
GUDID is an acronym for the Global Unique Device Identification Database — a central repository of detailed medical device information created by the US FDA. It is often pronounced “Good ID”. The GUDID system was implemented as a component of the FDA’s Unique Device Identifier (UDI) regulations, and serves as a digital repository of UDI information for all medical devices that are ‘placed’ in the United States (i.e. sold in the US market).
The GUDID system is designed to help identify and trace all medical devices sold in the U.S. market and provides detailed data about each device including labeler, manufacturer and production information, intended use, safety, and storage and handling requirements. The database is accessible to regulators, manufacturers, healthcare providers, insurers and the public at large.
What’s the goal for GUDID?
The goal of GUDID and UDI is to help improve patient safety, promote population health and facilitate traceability of medical products. For labelers (manufacturers), UDI will improve internal processes, bolster master data quality, enable more accurate compliance reporting, and provide visibility related to product recalls and counterfeit devices. Unfortunately, data submission methods via manual data entry or Excel spreadsheet uploads are time‑consuming and error‑prone, making it difficult for device labelers to achieve these goals. By implementing an automated, machine-to-machine (M2M) solution for GUDID data gathering & submission, medical device suppliers can achieve compliance with UDI requirements for the US, using automated data validation and data submission to enhance master data quality while reducing master data maintenance and IT costs.
The History of GUDID
How was GUDID implemented?
The GUDID was implemented as part of the FDA’s UDI system. This system requires that each medical device has a unique identification code, called the Device Identifier (DI), that is included in the device label (printed on the device itself or on its packaging) in both machine and human readable format. The UDI code contains information about the device, the labeler or manufacturer, and when/where the device was manufactured.
The FDA’s UDI program was established in 2013, when a ruling was issued to require all medical devices to carry a UDI by 2020. The GUDID system was specified as part of that same regulation, where labelers were required to submit their UDI data for electronic consumption in addition to printing the UDI on device packaging and labelling. The data submission requirements were phased according to different device risk classes between 2016 (Class III), 2018 (Class II) and 2020 (Class I). However, due to unforeseen supply chain disruptions resulting from the global COVID-19 pandemic, a 2-year extension was granted for Class I device submissions.
What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID?
Class I devices, and devices that have not been classified into class I, class II or class III but are required to be labeled with a UDI, must bear their UDI as a permanent marking on the device itself if the device is one that is intended to be used more than once and intended to be reprocessed before each use [§801.45]. However, not all devices that must be marked or labelled are required to have their UDI data submitted to the GUDID, for these exceptions and exemptions, please refer to the FDA’s various guidance documents.
What is the deadline for Class I medical devices?
Originally, class I and unclassified devices had to comply with UDI labeling by 2018, however, due to industry advocacy, the FDA extended its date for its UDI labeling rule for class I compliance by two years – until September 24, 2020.
As the COVID pandemic unfolded, the Agency announced it did not intend to enforce its compliance date for formatting, UDI labeling and GUDID data submissions for Class I and unclassified devices before September 24, 2022.
How do I become UDI compliant?
To optimise the process for GUDID compliance, we recommend the following four Critical Actions:
- Create an internal Global Data Syndication Hub (GDSH) to aggregate your internal product master data from its various data sources into this Global Data Syndication Hub for data enrichment, data validation and data submission.
- Enrich and validate the UDI data based on FDA-specific attributes, code value lists and validation rules.
- Submit your product/device data once it’s fully validated by the FDA rules such that it can be trusted and consumed by external stakeholders i.e. FDA, healthcare providers, GPO, clinicians and patients.
There are two ways to submit your validated device data to the GUDID today:
- Manually via the FDA’s GUDID web portal, or
- Leverage the expertise of a FDA‑approved “Third-Party Submitter” and their automated machine-to-machine (M2M) systems. Please ensure that your Third-Party Submitter’s system supports HL7/SPL messaging standards and GAMP5 system validation requirements for audit purposes.
How else can I make data compliance simple?
Get started today with Innovit’s GUDID.cloud system – the most cost-effective solution to help you prepare your regulatory data for GUDID Class I submissions and compliance.
To help you embark on this journey, visit Innovit’s GUDID Reference Center – your one-stop UDI knowledge base with everything you need to know about compliance with GUDID submissions.
Get started at no cost, with a free trial of Innovit’s GUDID.cloud system!