FDA Proposes Unique Device Identifier System for Medical Devices
On July 3, 2012, FDA proposed to establish a Unique Device Identification (UDI) system for most medical devices in the United States.
In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) to amend the Food, Drug & Cosmetic Act (FD&C Act). Section 226 of FDAAA includes requirements for FDA to promulgate regulations for a UDI system for medical devices.
Under the proposed rule, a UDI will include:
- A device identifier, a unique number or alphanumeric number specific to the device model
- A production identifier, which contains current production information including batch number, serial number, and expiration date.
A UDI will be placed on the label of the medical device or its packaging in a plaintext format that can be read by automatic identification and data capture (AIDC) technology. FDA plans to use AIDC technology to collect and publish information on UDIs in a publicly available database. The database would contain standard information for each UDI, but would not contain any patient information.
With the establishment of the UDI system, FDA hopes to provide a standard identifier that will identify problems more quickly, enable recalls, improve patient safety and create supply chain efficiencies.
Currently, the Unique Device Identification System is a proposed rule. It will be published in the Federal Registrar on July 10.
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