UDI Compliance

The new year is nearly here.

If you make sparkling wine, then you’re probably excited about the new year, as bubbly is bound to be in demand. If you’re an orthopedic medical device manufacturer grappling with compliance ahead of the FDA’s UDI Final Rule effective dates, however, you might be feeling a little less festive.

That’s because 2019 brings new compliance deadlines, the first in a series of rolling requirements set to take effect between 2019 and 2021. Against this backdrop, there is a lot of interest and concern about UDI compliance and its effect on orthopedic medical devices. What’s the best strategy to employ? 

Across the industry, companies are taking varied approaches to compliance, and some are still formulating a plan. At ImplantBase, we are developing features that support some of the facets of UDI compliance. But to support the real (and evolving) needs of the industry, our product development will require input from our existing and future customers. After all, it’s our goal to be fully ready when UDI compliance is an absolute known—and when you need us. 

Class II devices are still relatively simple. In some cases, they present a slightly higher risk, so there are slightly higher levels of regulation associated with them. Class II devices include, among others, powered wheelchairs and pregnancy testing kits.

Class III devices are the most complex—and are and will be subject to the most regulation. Of course, Class III is the category into which the vast majority of orthopedic implants fall, and so this is the regulatory class on which the industry is most focused.

Hence the UDI regulations, which are intended to inform chain of custody—or the traceability of something’s origin and the information on where it is now—and provide transparency that hasn’t existed previously.

• Sterile packing with UDI listed on the package label

• Breakaway, where the UDI is on a piece of the part that is separated and catalogued at the time of implantation

• Direct part-marking, where the UDI is permanently marked on the device itself

Direct part-marking, the last of these three, is what will eventually—as the FDA UDI Final Rule goes into effect—be the standard across the industry, for every part. (Of course, there will be exceptions, especially for parts that are only 1-2 mm wide, but this is what the FDA is saying at the moment.)

No matter which route you choose, orthopedic medical device companies will have to make sweeping changes to become compliant.

Of course the challenge of UDI compliance is complex enough when you’re contemplating how to comply while producing new products. But what about dealing with the inventory you already have in the field? If you have multiple brands and product lines, you have to bring each of them into compliance. And failure to achieve compliance before the deadlines go into effect could result in an adverse outcome from an inspection, like a Form 483 letter. While the FDA has issued guidance that effectively delays enforcement, compliance deadlines aren’t going to be extended forever.

Yet, while we’ve certainly done a deep dive into this issue and its ripple effects, we don’t have a crystal ball. As we mentioned early in the article, we’re sourcing input from existing and future clients to help us focus product and feature development on UDI compliance needs (and so we’re all ready when those regulations actually do take effect, between now and 2021). To that end, we’ll be releasing a short industry survey and, once responses are in, sharing some takeaways on our findings.

What are you doing to be UDI-compliant? How are you planning for future product launches?

ImplantBase is a leader in digital transformation for the orthopedic implant industry. Its platform provides manufacturers of every size with a unique cloud-based solution that transforms how the business operates on every level and across your critical functions of finance, sales, and operations. Learn more at implantbase.com.