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QUOTED. 16 October 2020. Toby Lowe.

Executive Summary

A new US FDA guidance document allows manufacturers of flu tests to make substitutions for some materials also used in COVID-19 diagnostics without notifying the agency. See how regulator Toby Lowe explained the move.

“This policy will help expand access to certain FDA-cleared molecular tests intended for the detection and identification of flu viruses.” – Toby Lowe, associate director for programs and performance, Office of In Vitro Diagnostics and Radiological Health, US FDA

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