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ENT device cassification

This article was originally published in The Gray Sheet

Executive Summary

FDA proposes to classify nasal dilators, intranasal splints and bone particle collectors into Class I and to exempt the devices from 510(k) requirements in a May 11 Federal Register notice. FDA's Ear, Nose, and Throat Devices Advisory Panel recommended placing the devices into Class I during a 1990 panel meeting ("The Gray Sheet" Oct. 29, 1990, p. 8). FDA says it had "inadvertently omitted classifying" these types of devices in 1986 when the agency published a final rule classifying ear, nose, and throat devices. Comments are due by Aug. 10...
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