The workshop helps you identify the requirements for the UDI elements:
- Procedure changes
- Label UDI
- Package UDI
- Direct marking UDI
- Date format
- Entry into GUDID
The workshop helps you implement the changes, update your procedures, and determine when you need to revalidate databases.
All medical devices marketed in the US, with limited exceptions, must have unique device identification. The first phase is the revised regulations with an effective date of Dec. 23, 2013.
The subsequent phases depend on device attributes such as regulatory class, intended use (life sustaining or life supporting), reusable & reprocessed, etc. FDA-CDRH published a simple table, by compliance date. However, device manufacturers need a more refined analysis to classify their products and determine the compliance dates.
For each compliance date, depending on the device characteristics, the manufacturer puts the UDI on the label, changes the label’s date format, includes the UDI on packaging configurations, and enters information into the FDA-CDRH database called the GUDID. In some case, the manufacturer puts the UDI on the device itself.
By September 24, 2016, all manufacturers of Class 2 devices must implement UDI (label, package, and GUDID). You need to understand the regulation and develop your plans now or you won’t be ready. There are a lot of details in the implementation and you will need time to handle all of them.
You need to plan your implementation. You have only two choices.
- You could assign somebody as the subject matter expert. This means reading and understanding the 160 page final rule as well as the ever changing guidance documents
- You could send your implementation team to this workshop designed to clarify the requirements and provide hand-on practice in the implementation