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Dura Substitute 510(k)s Should Not Require Follow-Up Imaging - FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

One-year follow-up imaging in patients with implanted dura substitute devices has little clinical value in performance assessment, members of FDA's Neurological Devices Panel agreed at a Sept. 16 meeting in Gaithersburg, Maryland.

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Dura substitute guidance

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)

Dura substitute guidance

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)

Panel Recommends Human Dura Mater Reclassification Into Class II

Processed human dura mater should be classified as a Class II device, FDA's Neurological Devices Panel unanimously (7-0) recommended Sept. 17 at a meeting in Gaithersburg, Maryland.

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