Medical device companies scrambling to meet UDI deadline

Editor's Note

A survey by Loftware, Inc (Portsmouth, New Hampshire), shows that only 15% of medical device companies are currently compliant with the next phase of the Food and Drug Administration's Unique Device Identification (UDI) regulation, the August 3 PRWEB reports. The deadline is September 24.

Of 120 companies polled, 93% said UDI requirements have had a major or at least noticeable impact on their existing labeling processes. Only half said they would be able to meet long-term UDI regulations and other evolving requirements as well as expand to new markets.

Other survey results show data collection and output continue to be a struggle as respondents cite getting all of the necessary data on the label (50%) and pulling labeling data from enterprise applications (45%) as their top challenges. They say their next biggest challenge is simply understanding and applying the regulation (36%).

"I can't stress enough the need to have your approach to UDI compliance be well thought through, well documented, and well implemented."