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Clinical Groups Call For 'Me-Too' Pathway For Infectious Disease LDT Approvals

This article was originally published in The Gray Sheet

Executive Summary

A group of infectious disease and clinical virology societies are asking FDA to establish an alternative under the agency's proposed lab-developed test framework for infectious disease test services. Clinical laboratories should be able to use commercial high-risk tests as predicates for ID LDTs so they won't have to go through the costly PMA submissions process.

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