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Reprocessed Device Labeling Guidance Evades OEM Trademark Issue

This article was originally published in The Gray Sheet

Executive Summary

The Association of Disposable Device Manufacturers believes that FDA's July 30 final guidance on labeling for reprocessed single-use devices does not preclude the agency from granting its request that reprocessed SUDs should be misbranded if they bear an OEM trademark.

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OEM Trademarks On Reprocessed Single-Use Devices Acceptable, FDA Says

FDA regulations do not require reprocessors to remove original equipment manufacturer (OEM) trademarks and references to OEMs from reprocessed devices, but the reprocessor must make clear that it, not the OEM, is the manufacturer of the reprocessed single-use device, FDA states in its Sept. 17 denial of a petition from the Association of Disposable Device Manufacturers.

OEM Trademarks On Reprocessed Single-Use Devices Acceptable, FDA Says

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Third-party reprocessors may lack the capacity to fulfill the demands of hospitals unable to comply with FDA's regulatory requirements for single-use devices (SUDs), scheduled to take effect Aug. 14.

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