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Class I IHC devices should not require 510(k) clearance, Incstar says.

This article was originally published in The Gray Sheet

Executive Summary

CLASS I IHC STAIN EXEMPTION FROM 510(K) REQUIREMENTS should be adopted by FDA, Incstar says in recent comments on FDA's proposed rule to classify immunohistochemical stains. Because Class I IHC devices are used for "minor clinical or decision making purposes," the company maintains that 510(k) exemption of IHC Class I devices "would save time, effort and money of both industry and FDA with little or no risk to health care."
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