clia categorization

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FDA issues revised final guidance regarding administrative procedures for CLIA categorization

By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”).  FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014).  The 2014 Guidance replaces the final guidance with the same name originally issued on May […]