Device companies struggle to meet UDI requirements: 4 things to know

Medical device makers are feeling the weight of the Food and Drug Administration's unique device identifier regulations.

Loftware and USDM Life Sciences conducted a nationwide survey that polled approximately 120 medical device industry professionals responsible for regulatory, IT and labeling practices. Results showed that only 15 percent of respondents said they are compliant with the next phase of labeling regulations.

The FDA introduced the unique device identifier system in 2013 to improve the tracking of medical devices from distribution to use. Since then, the agency has systematically established compliance dates for the healthcare industry to implement the new labeling requirements. While UDI labeling requirements will be phased in through 2020, all labels and packages of Class II medical devices must have UDI barcodes starting Sep. 24.

Here are four things to know about the survey's findings.

  1. About 93 percent of respondents reported that UDI requirements had a major, or noticeable, impact on their existing labeling processes.

  2. Only half felt their current barcode labeling software had the potential to meet long-term UDI regulations and international requirements, and help them expand into new markets.

  3. Most companies do not rely on a single solution for labeling. The survey found more than 70 percent of respondents use two to four different types of barcode labeling software.

  4. The respondents listed their top three challenges regarding meeting regulation standards as putting all necessary information on the label (50 percent), pulling labeling data from enterprise applications (45 percent) and simply understanding the regulation to apply it correctly (36 percent).

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