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IVD cadaveric sample labeling approval should be based on 50 matched samples -- FDA.

This article was originally published in The Gray Sheet

Executive Summary

HIV, HEPATITIS TEST CADAVERIC SAMPLE LABELING APPROVAL BY FDA should be supported by test sensitivity and specificity evaluation on 50 paired samples taken pre- and most-mortem, Robin Biswas, head of the Laboratory of Hepatitis in FDA's Center for Biologics Evaluation and Research, said at a June 21 public workshop in Bethesda, Maryland. FDA held the workshop to discuss issues related to the regulation of human tissue intended for transplantation and reproductive tissue.
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