In its comments, HSCA praised FDA for releasing guidelines to implement a UDI system while calling for a number of changes as well.
HSCA focused its comments primarily on the following recommendations:
- FDA should establish a single standard based on GS1.
- FDA should shorten the proposed seven-year phase-in to three years.
- FDA should adopt a policy requiring that if a device can be labeled, that it must be labeled.
- FDA should adopt the ISO standard for the date format on device labels.
“A UDI system properly aligned with widely recognized GS1 global standards will not only enhance patient safety and achieve numerous health benefits, but will also yield significant savings to the healthcare system that will far outweigh any costs incurred by manufacturers, suppliers or providers,” said HSCA President Curtis Rooney, in the release. “HSCA is committed to increasing efficiency in the healthcare supply chain through the adoption of global standards. We look forward to continuing to work with FDA to successfully implement the unique device identification system, which will help protect patients and remove healthcare costs from the system.”
To view HSCA’s comments to FDA, click here (pdf).
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