Are you on top of all this UDI stuff? And if not – shouldn’t you be? What I mean specifically, is that the USA’s Food and Drug Administration has recently made a ruling that anyone selling medical devices in the US has to add a new ‘unique device identification’ (UDI) to all of its labeling.
Plus – you also have to send details of your devices that regulator’s global unique device identification database The problem is, I suspect that many medical device manufacturers are not fully aware of what this entails, and those that do, have not yet set about creating a good system to meet the requirement.
As to the first point: there are a lot of devices that get classed by the FDA as medical devices … many of them a long way from an MRI scanner. It goes all the way down to things like tongue depressors and bandages. Although the details of the simpler devices don’t need to be submitted for a few years yet, the changes do affect these too.
And on the second point, the big obstacle there is that the data you need to properly collate for the database currently resides in lots of different places: it might need to come from your manufacturing systems, from accounting processes and or even from spreadsheets – it is never just going to be all in one place (until you create such a place – as we’ll see in a moment). Do you know how many class II and class III devices you have out there in the US market? Details of the class IIIs need to be sent to the FDA by September 24th this year and most of the class IIs two years later in 2016; do you have this in hand?
The good news here is that at least the information you have to package up is fairly clear. The problem is not therefore ambiguity, but scale. Most organisations that fall under the regulations will have lots of products they need to catalogue and track here.
How are we helping you here? Some of you may know that we have recently launched a special medical devices module for our RIM (Regulatory Information Management) solution.
In other words, you are now able to take advantage of a special Samarind module that will make it very easy to input and track the information you need to for the FDA database.
Even better, the module will also be a big aid to you in other areas, too – like keeping track of all your device and facility registrations worldwide, and anything else to do with the general marketing and the supply of your products throughout the world.
We are currently demonstrating the solution – and I hope you can get to evaluate it, as I think you will find it a very helpful aid in meeting this problem at the scale and level of accuracy you will want.