Class II medical device labelers may be surprised to realize that there are only 25 business days remaining before the FDA’s Class II UDI compliance date. By September 24, 2016, all Class II devices are required to bear a UDI on the label and be entered into the FDA’s Global UDI Database (GUDID).
Class II labelers need to consider the risk of noncompliance, evaluate their options for submission, be realistic about their chances of obtaining an extension and realize that they are likely to encounter delays if submitting in the final weeks or days before the deadline. They also need to have a solid plan for maintaining and managing their data records going forward.
If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?
It’s not too late to ask for help. Reed Tech experts have submitted 25% of the published UDI records in GUDID (as of May 1, 2016) and have more than ten years of experience helping Life Sciences companies achieve compliance through electronic submissions to the FDA.