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New US risk class for human dura mater

This article was originally published in Clinica

Executive Summary

The US FDA has announced that human dura mater has been categorised as a class II product subject to special controls. As a result, companies wishing to sell the human material to repair defects in human dura mater will need to comply with a new guidance when they submit their 510(k)s. The guidance recommends clinical and histopathological methods, such as next of kin interviews and full brain autopsy intended to identify and defer potential donors who have vCJD/CJD.

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