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FDA exemption of Class I, Tier I devices

This article was originally published in The Gray Sheet

Executive Summary

Several firms submit comments on the recently published FDA proposal to exempt 164 devices from 510(k) review. Urging that unscented menstrual pads be added to the group of exempted devices, Nancy Buc, lawyer for the Washington, D.C. firm Buc, Levitt & Beardsley, says that "if ever a product warranted an exemption, this is it." Coltene/Whaledent opposes the proposed exemption of retentive and splinting pins and root canal posts. Eliminating premarket notification requirements, the firm argues, would "result in substandard products being made available" that would become "part of permanent dental restorations, wreaking havoc on the...American public." The firm says that it manufactures a number of dental pins and posts that are preamendment devices as well as an active post under 510(k) clearance

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