FDA's Unique Device Identification Proposed Rule

The FDA's proposed rule on Unique Device Identification for medical devices was released on July 3, 2012. Congress directed the FDA to establish a unique identification system for medical devices.

What exactly is meant by UDI?

Unique Device Identification (UDI) will contain the device model and lot / production batch number. Other  details about the device, such as expiration date, may also be included. The UDI will be a numeric or alphanumeric code, and will also be in format that can be read by automatic identification and direct capture technology (for example, a bar code scanner). Below is a graphic depicting a sample UDI from the FDA's webpage on UDI. 

The goal of the rule is to facilitate identification of medical devices in the United States. Medical device manufacturers will provide a standard set of identifying elements to the FDA, to be populated into a database (Global Unique Device Identification Database - GUDID) that will be accessible by the public and health care community. No patient specific or personal privacy information will be listed in the database or connected to the UDI.

Consumer safety will be enhanced with this system. Unique identification of each device will facilitate 

• Accurate and targeted product recalls by manufacturers 
• Reduce errors by health professionals through a standard method of device identification
• Improve the data in post-market surveillance which can be used to in determining market-readiness of new devices or new uses of the same device

What medical devices will be impacted?

The FDA will implement the rule based on risk, starting with highest-risk medical devices. Some low-risk medical devices may not be required to carry a UDI. Devices sold over-the-counter may be excluded from the requirement since they generally have a UPC code in place.

Certain devices may also be required to have the UDI marked directly on the device. This will allow device identification even when it is separated from its labeling and packaging. 

"The types of devices that would be subject to the direct marking require are implantable devices; devices intended to be used more than once, and which are intended to be sterilized before each use; and stand-alone software. These types of devices have physical characteristics, or characteristics of use, that significantly increases the probability that the device will become separated from its label, particularly when used over an extended period of time." (Federal Register Docket No. FDA–2011–N–0090, Vol. 77 No. 132, July 10, 2012.)

How is your company preparing to implement the UDI ruling?

Graphic credit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm