UDI Exceptions, Exemptions and Extensions

July 22, 2016 Andrew Pfeifer

UDI_ExtensionAs the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant them an extension. Unfortunately, while certain devices are exempt from UDI and the FDA has allowed extensions in rare situations, for most of these companies, the answer is no.

Examples of devices exempt from UDI requirements include Class I devices exempted from good manufacturing practice requirements or devices used only for research or instructional purposes. However, these exemptions do not help most of the companies asking about a way around the 2016 deadline.

There is one exception built into the UDI Final Rule that Class II labelers can take advantage of to allow them a bit of breathing room. Finished devices manufactured and labeled prior to the deadline are exempt from UDI requirements for three years, giving labelers a chance to work through existing inventory without having to worry about every device on their shelves bearing a UDI on September 24.

Following the release of the Final Rule in 2013, the FDA has been receptive to feedback from the industry on requirements and has made certain accommodations in response to industry requests. For instance, after receiving and reviewing a challenge from the trade group Advamed on behalf of its members, the FDA extended the deadline for UDI labeling requirements for many non-sterile implants by one year to September 24, 2016. It is worth noting, however, that the FDA did not agree to other requested changes to the timeline—GUDID submission deadlines remained unchanged for these devices and Advamed had originally proposed a two-year extension.

The FDA has made other accommodations for categories of labelers who presented compelling cases, but these were based on factors such as the extraordinarily high volume of Device Identifiers required for contact lenses compared to other device types in the same class.

An individual labeler may submit an inquiry to the FDA Help Desk regarding exceptions or extensions. However, it should be prepared to make a very good case for why compliance with the Final Rule as written is not technologically feasible or why the labeler’s temporary inability to distribute product while implementing UDI requirements would be detrimental to public health. In the event of an exception request, labelers should be prepared to suggest an alternative to the established UDI procedures that would provide the intended benefits of the UDI system.

The FDA has stated clearly that “the phased implementation schedule outlined in the final UDI Rule gives labelers of class II devices adequate time to comply with the applicable UDI requirements by September 24, 2016. We expect class II labelers to be making diligent efforts to fulfill their UDI obligations.” In other words, a request that amounts to “we got a late start” is very unlikely to result in an extension. Remember, noncompliance can have serious consequences, including misbranding.

The good news is that help is available. If you are looking for immediate support, contact the team at Reed Tech—we are ready and able to assist Class II labelers in tough situations.

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