1. Parts of the UDI
There are two key parts to a complete UDI. The device identifier, which identifies the specific version or model of a device, and the labeler of the device, as well as the production identifier, which provides specifics on the date and lot or batch of manufacturing.
2. A UDI would have to include two versions
UDIs must be available in two versions, a plain text version label, as well as AIDC, utilizing automated electronic data systems such as RDIF or barcodes.
3. Alternatives to the Proposed Regulation
The device identifier is always static, or fixed. It includes the specific version or model of a device, and its manufacturer.
4. Product identifier process
The product identifier is always variable. It includes at least one of three things: the lot or batch number of production, the date of expiration, and the date of manufacturing.
5. Standards for UDI
There are three potential issuing agencies for your UDI. This includes GS1, HIBCC and ICCBBA.
6. Time Line for Compliance
Compliance dates are different for different classifications of products. For instance, Class III products had one year from final rule publication (September 24, 2014), and implantable devices and life supporting devices had two years from publication, with an overall seven-year, staggered period. It's important to understand your specific product classification and its corresponding compliance date.
7. Standard Date Format
For devices which fall under the one year compliance date, there is a one year extension available which may be granted by the FDA. This request must be submitted before the end of June, and must show the best interests of public health.
8. The Label Design Software
Software and stand-alone software must also follow proper UDI regulations, dependent upon how they are classified. UDI information for downloadable software must be easily displayed with plain-text statements through the program, and packaged and downloadable versions of the same software may have the same UDI.
9. Printing The UDI - The Label or Direct Mark
Planning ahead and following increased awareness is essential. It is your duty to understand your device business processes, regulatory and clinical affairs and compliance processes, quality-related documentation, and so forth. It is never justified to say "we should have known earlier or better"!
10. Contingency Planning
PASS-IT: Practical, Actionable and Sustainable Solutions based upon becoming familiar with requirements, determining what is relevant, mapping the processes impacted, and planning the implementation.
11. Implementation procedures
CASC-SI: Current, Accurate and Complete Information in a Systematic, Integrated manner, is crucial for implementation of UDI.