The Food and Drug Administration (FDA) released March 12 an updated guidance on categorization of laboratory tests. The document, “Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff,” replaces a document issued in May 2008. CLIA refers to the Clinical Laboratory Improvement Amendments of 1988. The FDA noted that the…
FDA Updates 2008 Guidance on Categories of Lab Testing
by Glenn S. Demby | Feb 25, 2015 | CLIA-nir, FDA-nir, National Lab Reporter | 0 comments