The size of your product portfolio can determine the complexity of your GUDID submission process.
GUDID submissions represent a substantial investment of time and resources that grows in relation to the size of your product portfolio. Manufacturers that only have a handful of medical devices may be able to easily and efficiently use FDA’s GUDID web interface. But with thousands or even tens of thousands of devices requiring a total of 62 individual device attributes to be collected and submitted to the GUDID, important factors begin to emerge that can affect whether your company can comply with UDI labeling deadlines set forth in the final rule.
Really, the entire process is manageable if you know where to begin in identifying and collecting the necessary data. By starting early and keeping a few key things in mind when considering the best GUDID submission option for your company, you can successfully meet upcoming UDI compliance deadlines.
Read “US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know” from the November 2014 issue of Regulatory Focus for some pointers in creating a UDI compliance plan.
What other GUDID submissions best practices have you encountered? Share your observations in the comments below.