FDA publishes final device identifier rule

The US Food and Drug Administration has finalised its rule for the unique device identification (UDI) system to help track medical devices.
 
The UDI system is intended to improve adverse event reporting, allow easier recall of devices, fight against counterfeiting, and improve patient safety.
 
A legal requirement for the FDA to develop a UDI system was put in place in 2007, when legislation mandated a system to allow identification of medical devices through both use and distribution as an addition to existing labelling requirements.
 
The FDA notes that the UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device. This identifier will also include production-specific information such as the product's lot or batch number, expiration date, and manufacturing date if that information appears on the label.
 
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier, with no link to patient-level data.

Alongside the final rule is draft guidance for manufacturers outlining how to submit information to the GUDID.
 
"UDI represents a landmark step in improving patient safety, modernising our post-market surveillance system for medical devices, and facilitating medical device innovation," said Dr. Jeffrey Shuren, who is director of the FDA's Center for Devices and Radiological Health.

The FDA plans to phase in the UDI system gradually, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

The European Commission (EC) is also implementing measures to improve the oversight of medical devices, and has set up a working group to draft recommendations and guidelines to ensure that the US UDI will be globally compatible with a framework proposed in the EU earlier this year.

The recently set up International Medical Device Regulators Forum - which includes representatives from the US, Europe, Latin America and Asia - is also working on a harmonised UDI system.

Among the changes introduced by the FDA compared to older versions of the UDI are: a new standardised date format designed to be close to the system used in the EU and elsewhere in the world (YYYYMMDD); a three-year exemption of existing inventory; no requirement for UDIs on implantable devices; the need for a UDI on the pack only for single-use devices; and a one-year compliance extension for class 3 devices such as pacemakers and heart valves.

"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development," said Shuren.