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Extended comment period for IVDMIA guidance

This article was originally published in The Gray Sheet

Executive Summary

Stakeholders have until Oct. 17 to submit additional comments on FDA's draft guidance on in vitro diagnostic multivariate index assays. A 30-day comment period on the agency's revised draft, which would assert FDA enforcement over certain lab-developed tests, initially closed Aug. 27, but critics said there had been insufficient time to thoroughly evaluate the guidance's implications (1"The Gray Sheet" Sept. 3, 2007, p. 7)

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