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In Brief: FDA 510(k) exemptions

This article was originally published in The Gray Sheet

Executive Summary

FDA 510(k) exemptions: Regulation takes effect Feb. 15, making 122 categories of devices Class I and exempting them from premarket notification requirements. The final rule downclassifying and exempting 111 devices and exempting 11 Class I devices was published in the Jan. 15 Federal Register ("The Gray Sheet" Jan. 22, p. 6)...
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