September 24th! The day that the UDI is required for medical devices. Class III Manufacturers - your day is TODAY! Class II Manufacturers - you have 2 years to be ready.
The dates are defined here on the FDA site.
It has been a long time coming. The legislation started back in 2007. The goal of UDI and the mandatory compliance is to enhance the public health. If a device has a UDI, it can be tracked more easily in the event of a recall.
But, there are many more advantages to UDI compliance than just obeying the law. Manufacturers now have the ability to better integrate their supply chain.
Here are X items to be aware of to get the most out of your UDI effort:
- Connect your devices to your ERP manufacturing system before shipment. Ideally, your device in the "wild" can still be tracked throughout its travels... with a complete listing of all of its components.
- Connect your device with EHR
