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Hood Laboratories downclassification petition for valved endolymphatic shunt denied by FDA.

This article was originally published in The Gray Sheet

Executive Summary

HOOD LABS' VALVED ENDOLYMPHATIC SHUNT TUBE DENIED CLASS II STATUS by FDA in a Dec. 9 Federal Register notice. Denying a reclassification petition filed by E. Benson Hood Laboratories in May 1990, FDA says the firm failed to "present sufficient new scientific information" to address the safety and efficacy concerns related to: the range of physiological pressures within the endolymphatic sac; the mode of action of the endolymphatic shunt tube with valve; and the flow characteristics attributable to effective functioning of the valve.
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