The FDA has recently updated its draft version of the UDI rule to include its proposal for the UDI system and tracking database. The Global Unique Device Identification Database (GUDID) would keep track of all medical devices’ unique identifiers.
In a previous draft (July 2010), the FDA defined a phased in approach to compliance depending upon the device’s classification: Class III devices, such as implantable pacemakers, must comply with the new rule within a year of final passing, Class II devices, medium risk products like infusion pumps, must comply within three years, and Class I devices, low risk products like hand-held surgical instruments, must comply within five years
In the updated draft, the FDA has decided that all implants, life-sustaining, or life-supporting devices must comply with the UDI rule within two years. This includes any subset of Class II devices that fall into this category. Class III devices are unaffected by the draft update.
Medical device manufacturers whose products must comply sooner rather than later need to prepare for the final ruling. How will you label your products? If you are marking products with a label, then you need to be sure the ink and label material work together properly for correct contrast so that the label is machine readable when the product is used in an operating room.
You’ll need to have a printing system that can handle dynamic data, because although the UDI will stay the same for a product, lot numbers, serial numbers, and expiration dates will change.
What kind of Auto ID carrier will you use? The FDA doesn’t dictate which type, so you can use a linear bar code, 2D matrix or RFID. However, hospitals, clinics, and other healthcare organizations use all types of technologies for auto ID, so it makes sense to know how your label is going to be read by the end user.
The proposed rule requires direct part marking (DPM) for implantable devices, and devices intended to be used more than once and that are to be sterilized before each use. DPM is required two years after the device is required to have a UDI on its label. However, a device might fall into the exemption category if direct marking interferes with the device’s safe use, or if marking is not technologically feasible.
If you are facing UDI, talk to us. We can help you put together the labeling systems that will meet FDA requirements.