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Dura mater guidance

This article was originally published in The Gray Sheet

Executive Summary

Comments are due Jan. 12, 2000 on the agency's draft "Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater," one of several special controls cited by the Neurological Devices Panel in its Sept. 16 recommendation to classify processed human dura mater as a Class II device (1"The Gray Sheet," Sept. 20, p. 6). Last revised in August, the document addresses product characterization, specifications, manufacturing controls, and labeling issues

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