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In Brief: IVD compliance policy

This article was originally published in The Gray Sheet

Executive Summary

IVD compliance policy: Availability of FDA's draft compliance policy guide on commercialization of in vitro diagnostics labeled for research or investigational use is slated to be announced in the Jan. 5 Federal Register. "Except in specified instances, FDA does not intend to initiate enforcement action for 18 to 30 months" after release of a final CPG against companies surreptitiously commercializing tests by labeling them for investigational or research use "provided the IVD manufacturers...take steps to obtain FDA approval," according to the announcement. Required steps "include undertaking, by six months" from publication of the final CPG, "any necessary clinical investigations or other studies."...
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