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FDA EXEMPTS 148 CLASS I, TIER I DEVICES FROM 510(K) REQUIREMENTS UNDER FINAL RULE; JURY STILL OUT ON 16 OTHER PRODUCTS PROPOSED FOR 510(K) EXEMPTION

This article was originally published in The Gray Sheet

Executive Summary

FDA has put on hold decisions on whether to eliminate 510(k) requirements for 16 of the 164 Class I, Tier I devices originally proposed for exemption, reducing to 148 the number of devices exempted in a final rule to be published in the Federal Register the week of Dec. 5.
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