1
CLIA Waiver Guidance
n
nCarol C. Benson1 and Marina V. Kondratovich2
n
n          1   Associate Director,
n        Division of Chemistry and Toxicology Devices, OIVD,
n        CDRH, FDA
n         2 Statistician,
n        Division of Biostatistics, OSB, CDRH, FDA
n
nFDA-Industry IVD Roundtable Meeting,
nMay 11, 2006