The Federal Drug Administration (FDA) established the Unique Device Identifier (UDI) ruling in 2013 as a system to provide traceability for medical devices throughout their lifespan. Global UDI implementation has been rolling out in annual phases since 2014, addressing the higher-risk devices first.
The next deadline takes effect September 24, 2018. The ruling impacts class II devices, as well as the labels and packages for Class I, II, and III.
Complying with UDI regulations can seem confusing, but with the right direction, can be deployed without disrupting the business’s operation. However, non-compliance is much more debilitating. Penalties can include substantial fines, product recalls, and the suspension of a company’s distribution in the United States. The cost of failing to comply with UDI could run into millions of dollars.
The UDI rules apply to the full spectrum of businesses known as “device labelers”:
- Device manufacturer
- Contract manufacturer
- Private label distributor
- Convenience kit assembler
The UDI consists of two identifiers:
- The device identifier (DI), which includes fixed information (the labeler and the device’s specific version or model).
- The production identifier (PI), which 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’s UDI label requirements are very specific, from the label’s information to its durability for the life of the device. The labeler must use the correct format, and should have a reliable labeling system to avoid downtime. This includes a thermal printer capable of producing quality output, plus label media that will stand up to the conditions that it might endure (e.g., extreme temperatures and harsh chemicals).
Are you ready? And are you sure that you’re complying with the devices that are already covered by UDI mandates? Cal-Sierra Technologies works closely with compliance and regulatory programs. We can review and assess your UDI labeling system to make sure you’re meeting all requirements. Contact us to avoid the non-compliance penalties, delays, and expense of UDI non-compliance.