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Nasal dilators for temporary conditions should be included in device description -- CNS.

This article was originally published in The Tan Sheet

Executive Summary

NASAL DILATOR USE FOR TEMPORARY CONDITIONS as well as structural abnormalities of the nose should be reflected in FDA's description of the device, Breathe Right nasal strip marketer CNS states in Aug. 7 comments to the agency. The Minneapolis-based medical device marketer submitted the comments in response to FDA's May 11 proposal to classify nasal dilators as Class I (general controls) devices exempt from premarket notification (510(k)) requirements. Comments on the proposed rule, which includes a proposed description for nasal dilators, were accepted through Aug. 10.
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