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OTC medical devices "might find their way back into final UDI rule", warns US FDA

This article was originally published in Clinica

Executive Summary

The US Food and Drug Administration has warned manufacturers of over-the-counter (OTC) medical devices that their products may not be exempt in the end from the requirements of the unique device identification (UDI) rule that the agency is finalizing for medtech products and expects to publish in June.

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