FDA Opens Up Access to UDI Database

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that as part of efforts to keep track of devices throughout the supply chain, the Food and Drug Administration (FDA) has teamed up with the National Institutes of Health's National Library of Medicine to make data on unique device identifiers (UDI) publicly available online.

The AccessGUDID website is designed to allow researchers, members of industry, and the public to search and download information that  labelers-typically manufacturers-have submitted about their medical devices to the FDA’s Global Unique Device Identification Database (GUDID).

The website complements the UDI system, which requires a 10-digit numeric or alphanumeric code on all device packaging and labeling and on certain devices themselves. The code consists of two parts: a fixed portion identifying the labeler-typically the manufacturer-and the device model, and a variable portion that can provide information such as the serial number and product expiration date. The system was formally established in September 2013 and is intended to identify and track all products sold United States, allowing officials to  flag products with safety issues more quickly.

Unlike all prescription and over-the-counter drugs, which have individual identifying numbers known as National Drug Codes, "many medical devices currently do not have a unique identifier that clearly distinguishes one product from another," the agency noted. "The UDI system will provide a consistent and standard way to identify medical devices throughout their distribution and use by healthcare providers and patients."

The UDI system is being implemented in phases through 2020, and labelers are currently submitting data on only the highest risk medical devices.

Users may search AccessGUDID for specific medical devices or download all of the data at once. Updated daily, the website contains the most recent information submitted to the FDA on each device.

Industry, healthcare providers, patients, and other interested parties are encouraged to provide feedback to the FDA on the AccessGUDID to help determine additional enhancements.

Source: AAMI