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What’s the real cost of UDI compliance?


As we speak with Class II labelers, we often find very little thought has been given to submitting their UDI data to the FDA. Many industry members have been working for months on their UDI labeling processes but have left data submission for the very end. Unfortunately, they may be underestimating the time, effort and risk involved in submitting their records through the FDA’s Web Interface.

There is no fee to use the FDA’s GUDID Web Interface, but that doesn’t mean there isn’t a cost. Device companies need to consider the additional costs that may arise from their chosen submission method.

UDI team leaders should ask themselves important questions about the total costs of their UDI data submission and management plan:

  • ​What are time costs of manual entry into the Web Interface for my team?
  • What’s the opportunity cost, the things that won’t get done while they’re entering the records?
  • What are the potential costs of a data error that we don’t discover until after our device records have been published and product has shipped?
  • What’s the cost of starting from scratch to meet UDI mandates outside the U.S.?
  • What’s the potential cost of missing the deadline?

There are just 30 business days remaining before the September 24 compliance date! If you need help meeting the UDI deadline, understanding your options and controlling your short- and long-term costs, contact Reed Tech. We’ve assisted more than 190 medical device labelers of all sizes in meeting UDI requirements and submitted 25% of all published GUDID records(as of May 1, 2016).

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