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Audiometer 510(k) exemption request

This article was originally published in The Gray Sheet

Executive Summary

Thirty-day comment period on the Hearing Industries Association's petition requesting an exemption from premarket notification requirements for audiometers (21 CFR 874.1050) ends Dec. 18, FDA says in a Nov. 18 Federal Register notice. Received by the agency on Sept. 30 ("The Gray Sheet" Oct. 5, p. 19), the petition must be acted on by FDA within six months of receipt or it will be deemed granted according to Sec. 206 of the FDA Modernization Act
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