What the UDI could look like
(Courtesy of the FDA)
FDA issues final rule on UDI for medical device companies
September 20, 2013
by Carol Ko
, Staff Writer
On Friday, the U.S. Food and Drug Administration announced that it has finalized a new system requiring a Unique Device Identification (UDI) to identify medical devices.
The UDI is intended to help track reports on adverse events associated with medical devices, which are currently widely underreported.
Officials hope that better, more accurate data on such events will provide the FDA and manufacturers with information to help them identify product problems, issue recalls, and improve patient safety with greater speed and efficiency.
The UDI system requires that device manufacturers assign a unique number to the model of a device, called a unique device identifier, which will also include production-specific information like the product's lot or batch number, expiration date and manufacturing date.
The FDA would also create a publicly searchable database that would serve as a reference catalogue that stores information for every unique device with an identifier.
However, implementing this new rule will be costly and challenging for manufacturers, who will need to integrate UDIs into their existing information systems, test bar code software and train employees. They will also have to redesign device labels and install equipment needed to print and verify the UDI labels.
"This is one of the most expensive rule makings that I have seen in years as far as the impact on each and every company out there," said Janet Trunzo, senior executive vice president, technology and regulatory affairs at AdvaMed, during a media conference call on Friday.
The FDA amended some of its proposed requirements based on industry concerns. Single-use items, for example, now require only one UDI for the entire package, not for each individual item.
In addition, implantable devices now have no direct marking requirements due to concerns around cost and complexity. "We were very concerned about that, because in general putting marks on implants is not technically feasible, and in many cases would impact the safety and effectiveness of the device," said Trunzo.
The FDA's latest draft now specifies that MRI compatibility information on a device needs to be entered into the global UDI database, but doesn't need to added to the device itself.
Manufacturers won't have to worry about relabeling or destroying products currently in inventory, since the FDA has given three years of leeway for products already on the shelves.
The agency plans to implement the new system in gradual steps, focusing first on high-risk medical devices (Class III), which will be required to carry UDIs on their label and packaging within one year. Manufacturers will have three to five years to act for most moderate to low-risk products.
"UDI is not about just ticking a regulatory box, it is about all parties having a 360-view of the health care supply chain," GHX CEO Bruce Johnson said in a statement.