In 2013, the Federal Drug Administration (FDA) established the new ruling on medical device labeling. The Unique Device Identifier (UDI) rule has been launched in annual phases, and the third deadline will be reached on September 24, 2016.
This third phase addresses UDI labels for Class II devices, defined as medium risk (e.g., hearing aids, anesthesia breathing circuit, orthodontic wire, infusion cannula, feeding pump, sterilization tray). Manufacturers and labelers will need to ensure their product and packaging labels comply with the FDA regulations in order to avoid penalties, which could include a very costly recall.
This next deadline requires that the labels and packages for Class II devices must carry a UDI. The UDI rules apply to “device labelers,” which covers a broad spectrum of entities:
- Device manufacturer
- Contract manufacturer
- Private label distributor
- Convenience kit assembler
The UDI is comprised of two distinct identifiers: the device identifier (DI) and the production identifier (PI).
The DI provides information that is fixed: the labeler and the specific version or model of the device.
The PI contains variable information pertaining to that specific device, such as the lot or batch number, serial number, expiration date, and production date.
All of the UDI information must be submitted to the FDA-administrated Global Unique Device Identification Database (GUDID). This database catalogs all device identification.
The FDA is very specific about the requirements for a UDI label, from the information contained on that label to its durability for the life of the device. You’ll need to have the correct format for your labels, as well as a reliable thermal printer to produce quality barcodes, and the label media that will withstand the full range of conditions that it might endure — e.g., extreme temperatures and harsh chemicals.
Lowry Solutions’ Compliance Specialist has invested considerable time and effort into understanding every facet of UDI compliance and medical device labeling. With the deadline fast approaching, contact us to ensure UDI compliance.