On 20 September the U.S. Food and Drug Administration announced the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
FDA News release says, UDI represents a landmark step in improving patient safety, modernizing post market surveillance system for medical devices, and facilitating medical device innovation.
As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device.
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, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when 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. No identifying patient information will be stored in this device information center.
UDI system will help trace the devices quickly in analyzing any adverse events. A more robust post market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices. It will also help to efficiently manage Medical devices recall. Finally UDI system will serve a foundation for global distribution chain and help address counterfeiting.
Compliance dates for UDI implementation are defined in UDI rule. In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
For more information refer
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
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