There are only 157 working days until the Sept. 24, 2016 Unique Device Identification (UDI) submission deadline for Class II devices. Now is the time for labelers to begin preparations for submitting their UDI records to the FDA’s GUDID database.
“Some GUDID submissions just sail through,” Reed Tech UDI expert Gary Saner told a webinar audience recently, “and yet there seem to be other records that are just problematic.” An early start will allow time for companies to address and correct any data issues before they become significant problems.
What should you be on the lookout for as you prepare your data?
While processing clients’ Class III and I/LS/LS device records, we noticed more than a dozen types of data-related errors that resulted in submissions being rejected by the FDA. Here is a just a handful of examples of the error types we observed frequently:
1. Incorrect Data Values: Information was transposed, omitted, or damaged by a typographical error. To avoid incorrect data values, you need to perform thorough quality checks of the data you are submitting.
2. Wrong Formats: While the data being submitted was correct, it was presented in the wrong format. The GUDID requires specific formats for data in each field. Check to make sure your formats match those of the GUDID system. If they do not match, you’ll need to convert your data to the correct format.
3. Product Identifier (PI) incorrectly included in the GUDID submission: PI data is not part of the required dataset for submission to the GUDID. Do make sure you are including the Device Identifier (DI) entries in the proper fields.
4. An invalid FDA listing number was submitted. It is important to double-check the number. To find the correct number, look back at the original device application and use the listing number that was assigned by the FDA at that time.
5. The Device Description field was left blank. This field should be completed. The FDA has suggested that you enter the approved/cleared indications for use of the device.
In our UDI work with device labelers in 2014 and 2015, we also came across errors involving incorrect reporting of package configuration data, problems with recent GMDN codes, and incorrect association of direct marking or packaging data with base product DI.
As these examples demonstrate, the UDI submissions process is complex. The FDA has a UDI Help Desk, but it will be under increased demand from the large number of Class II labelers submitting data in 2016.
We are urging our clients who label Class II devices to develop a comprehensive UDI submission plan and timeline as soon as possible. Develop and test the new processes that your plan requires. Include time in your plan to correct any errors you encounter during the submission phase.
Reed Tech can help take the stress out of completing a successful UDI submissions plan. Contact us today to start a smooth and uneventful UDI submission process.