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CLIA

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers seeking high or moderate categorization of 510(k)-exempt in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988 should send two copies of the product insert with regulation number citation, classification, and product code to FDA's Division of Clinical Laboratory Devices, according to a draft guidance released Aug. 14. Comments on administrative procedures for CLIA waiver and categorization are due in 90 days
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