Dura substitute guidance
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers of animal derived dura substitutes should provide information on the species and animal from which the substitute was derived, Nov. 9 FDA guidance recommends. Firms should also answer questions on how the health of the herd is maintained and monitored, the document states. In 1999, FDA's Neurological Devices Panel recommended that one-year follow-up imaging was of limited clinical value in performance assessments (1"The Gray Sheet" Sept. 27, 1999, p. 9)