Time is Up! Class II UDI Deadline Tomorrow

September 23, 2016 Dan Henrich

For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.

If your company is one of those labelers that managed to comply fully with the labeling and data submission requirements of the UDI Final Rule, well done! Take some time to pat yourself on the back, but get prepared to address maintenance issues because UDI is an ongoing standard, not a once-and-done project.

If you are counting on the FDA’s recent extension announcement to cover your device portfolio, make sure you understand the full implications of the policy. The extension covers only a few very specific categories of Class II devices. If you are at all unsure whether the extension applies to your devices, contact the FDA Help Desk for clarification. If the extension does apply to some of your products, keep in mind that does not change your UDI compliance date for the rest.

Yours may be one of the companies that are simply not going to make the deadline. With only hours to comply, there is probably little you can do at this point to change that. However, you should still keep working towards full compliance as soon as possible.

The FDA has not articulated a clear enforcement policy on UDI yet. However, there are several key things we do know that should incentivize labelers to comply as soon as possible. Most importantly, devices not in compliance may be considered by the FDA to be misbranded.

If you are struggling along, trying to comply as quickly as possible but encountering trouble, contact Reed Tech. Our team of UDI experts can help you size up your situation and find the fastest way to compliance.

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