Summary: 2018 continues the rollout of the FDA UDI for medical devices. Class II devices need to be 100% labelled, class I device packaging needs a UDI, and any non-classified medical devices need UDIs on their packaging.
As you probably know, the Food and Drug Administration is in the process of ushering in unique device identifiers for every medical device.
This plan has been phased in since since 2014 and is set to complete in September 2020.
Here’s what you need to know to stay compliant in 2018.
First: what is the FDA’s UDI plan?
The FDA is implementing UDI for medical devices that’s both machine and human-readable.
The FDA gives a few reasons for this work:
- Better reporting
- Reduced errors & faster error correction (e.g. recalls)
- Link device use to electronic health records
- Make the medical supply chain more transparent
UDI for medical devices will also power a public database, where FDA UDI access is granted to everyone.
And as lovers of data and transparency, we’re pretty excited about that.
UDI medical device plan to date
Here’s the rapid-fire timeline of FDA UDI regulation so far:
The FDA started their plan in 2013 and the first changes rolled out a year later. That year, they required labels to be put on all class III medical device software. These also had to be submitted to the FDA UDI database.
The FDA extended their control for class III controls to the rest of the class III devices — things like pacemakers and life support machines.
The FDA closed any remaining class III loopholes so that all medical devices in class III were in the database. The FDA also started rolling out UDI for medical devices in class II. Class II devices are things like wheelchairs and pregnancy tests. This is a big category — 43% of all medical fall in this category.
What new in 2018
And that brings us to 2018. There are 4 new FDA UDI requirements for medical devices.
- Class II devices need to be labeled with UDI on the actual device (not just the packaging)
- Class I devices (stuff like bandages and other non-deadly or mission-critical medical supplies) have to have a UDI marked on their packaging somewhere.
- All exemptions or exceptions from the class system need to be submitted to the UDI database.
- Class I software (e.g. software that, if something goes wrong, doesn’t cause that big a problem). Has to be labeled with a UDI. This only applies to stand-alone software.
What’s next for UDI for medical devices
The FDA UDI for medical devices is going to come to a close in 2020 with the final rollout of requirements. All device classes will need UDIs on the device themselves and any exemptions or loopholes will be closed by then. What’s more, failure to comply will begin to have consequences as the FDA regulates and enforces their rules.
Staying on-side of the FDA isn’t an optional activity for medical device manufacturers. Not only is the US medical device market enormous, but it’s growing.
But more regulation doesn’t have to to be a burden. A public database of what medical devices are in use is a hugely valuable asset for device manufacturers to better understand the marketplace and can help drive product innovation.
And better market insights is never a bad thing.
Photo credit: rawpixel via Pixabay
Struggling to stay on side with rigorous FDA and GS1 regulation? We can help. Get in touch to see how our cloud PLM can streamline compliance in just two weeks.