GUDID stands for the Global Unique Device Identification Database. It is a publicly accessible database maintained by the U.S. FDA. The GUDID contains information about medical devices that are labeled with a Unique Device Identifier (UDI).
The UDI system was established by the FDA to improve the identification and tracking of medical devices throughout their lifecycle, from manufacturing to distribution to patient use. The UDI consists of a unique numeric or alphanumeric code that is encoded in both human-readable form and machine-readable form (usually in a barcode or RFID tag).
Manufacturers of medical devices are required to submit information about their devices, including the UDI, to the GUDID. This information typically includes details about the device’s manufacturer, brand name, model number, expiration date, and other relevant attributes. The GUDID serves as a central repository of this information, allowing healthcare providers, regulators, and the public to access accurate and up-to-date information about medical devices.
The GUDID plays a crucial role in enhancing patient safety, facilitating device recalls, improving supply chain management, and supporting post-market surveillance of medical devices. It provides a standardized and comprehensive database that enables better traceability and identification of medical devices, contributing to the overall quality and safety of healthcare.
Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.
Sudha S
Regulatory Consultant
Office@libertymanagement.us