Devices & Diagnostics, Hospitals, Policy

Device trade group asks FDA to clarify and change proposed rule on unique device identifiers

The Food and Drug Administration’s proposed Unique Device Identifier code system is sometimes described as […]

The Food and Drug Administration’s proposed Unique Device Identifier code system is sometimes described as giving the industry a track and trace mechanism akin to the bar codes that forever changed the supermarket industry.

In July, FDA  introduced proposed that regulation requiring many devices in the U.S. to bear two codes. One is an alphanumeric code called the device identifier specific to a device model. They will also bear a production identifier containing production information regarding the lot or batch number, serial number and an expiration date among other data. The system would help the agency boost recall efforts, among other things.

Now at the close of the comment period Wednesday, industry group AdvaMed is requesting that certain changes be incorporated in the final regulation expected to be issued next year.

“We believe that it is the most extensive and complex FDA regulation to be issued in recent memory,” said Janet Trunzo, executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), in a conference call with reporters.

She added that it is “imperative that FDA get it right the first time.”

Here are some of the changes that AdvaMed is requesting FDA to make in the final rule, according to Jeff Secunda, vice president of Technology and Regulatory Affairs at AdvaMed.

  • Under the proposed rule, Class III devices have one year from the issuance of the final rule to implement UDI in their devices and become compliant. AdvaMed is asking that the time be extended to two years, with no timing changes for less riskier and less complex Class I and Class II devices. “One year just isn’t enough,” Secunda said.
  • FDA wants companies to decide when it is appropriate to be exempt from directly marking the device, where the physical device has to bear the UDI and not just the labeling or the packaging. But AdvaMed feels this is ripe for enforcement problems because FDA may disagree with the company’s decision on exempting a device it sells and send warning letters. To remove the potential for this, AdvaMed wants FDA to provide a “list of devices that are intrinsically unmarkable,” Secunda said. Those would include coronary stents that are too small to mark; amorphous devices like bone cement that has no structure to mark as well as absorbable devices where marking would be redundant since the body absorbs it.
  • AdvaMed is also questioning the premise for requiring implants to be marked directly at all when it would be more efficient to link the device’s UDI from the label directly into a patient’s electronic health record.
  • FDA’s proposed rule has an exception to direct marking of Class I devices that are sold in a dispensing pack – for instance hypodermic needles where each needle doesn’t need to bear a UDI, but the dispensing box does. However, Class II devices are not exempt. AdvaMed is requesting that  FDA extend the direct marking exemption to all devices that are sold in a pack and not individually.
When the agency issues the guidance, it estimated that over 10 years the measure will cost the industry$499.4 million at a 7 percent discount rate and $571.5 million at 3 percent discount rate.

[Photo Credit: Big Changes Ahead from Big Stock Photo]

Shares0
Shares0