Everyone has an Opinion on Unique Device Identification

The 221 comments are as diverse as the device market itself.  As was the case when the FDA first held its public meetings on the UDI initiative, most stakeholders recognize the potential benefit of an appropriate UDI system in improving post-market surveillance of medical devices and other related benefits. However, it also appears that there remains a large split of opinion on what technology is most appropriate to achieve these benefits. The FDA has attempted to duck this issue in its rulemaking by, for example, exempting over-the-counter devices and QSR-exempt Class I devices from the production identifier requirement and by allowing for the use of multiple standards (i.e., GS1, HIBCC) for UDI. It is clear from the comments that the issue remains unsettled in the minds of stakeholders and, without clear guidance from the agency, it is uncertain how manufacturers can ensure that their chosen UDI standard will not create unforeseen regulatory risks.

Upon review of a sample of comments, it appears that most make procedural and practical suggestions regarding UDI implementation for specific devices and/or advocate for exemptions.  A few comments oppose allowing multiple standards for UDI, on the grounds that a single UDI standard and system would be easier to implement into manufacturing operations. Many comments state that the rule needs to allow more time for manufacturers to implement UDI due to cost and logistics, whereas a few state that they are already compliant with the proposed rule and that implementation should occur sooner than proposed.

Other issues include, without limitation:

• Certain devices are difficult or impractical to mark;
• Products labeled before the UDI rule is implemented should be exempt due to burden and expense; and
• The ability (or lack thereof) of a remanufacturer to comply with the rule and proposals for exemptions for various reprocessed devices.

Larger companies that manufacture multi-component devices noted there is little direction regarding UDI labeling for their devices and that such labeling may not be practical.  For smaller manufacturers, many take issue with the cost of complying with the UDI rule, citing the financial crisis and the looming medical device excise tax, urging that the rule be postponed until after there is an economic recovery.  FDA has estimated the cost for domestic labelers alone to be $67-68 million per year, annualized over 10 years. Some comments, however, claim this number to be much larger.

The list goes on and on, and there are many contrasting opinions, some which may be practical for one device or manufacturer but not for another.

On November 19, the FDA unveiled an amendment to the proposed UDI rule.  The amendment accelerates the timeframe to implement UDI for some “implantable, life-supporting, or life sustaining devices.” The amendment also requires a UDI mark on implantable devices to be implemented within two years. Comments on the amendment will be accepted until December 19, 2012. The FDA also requested specific comments regarding its change in the definition of “custom devices” which are exempt from the UDI rule.  Comments to this inquiry are due January 18, 2013.

It will be a time-consuming and difficult challenge for the FDA to reconcile and address all comments in the preamble of a final rule. The fact that the FDA has amended the proposed rule and is asking for additional comments is helpful but, as a result, it is likely that we may not see a final rule for some time. What is certain is that the Agency is tasked with a delicate balancing act in considering the benefit to the public and safety risks, as well as the impact and burden on the medical device industry.