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FDA 510(k) EXEMPTION OF 62 CLASS II DEVICES ON JAN. 21 BRINGS TOTAL TO 636; RULE INCLUDES 30 IVDs, BUT DOES NOT APPLY TO POINT-OF-CARE TEST SYSTEMS

This article was originally published in The Gray Sheet

Executive Summary

FDA exemption of 62 Class II devices from 510(k) review in a Jan. 21 final rule brings to 636 the total number of products that no longer require premarket evaluation. The final rule was published two days after the 60-day deadline stipulated in the FDA Modernization Act, which was signed into law Nov. 21.

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