CLIA extension
This article was originally published in The Gray Sheet
Executive Summary
The Health Care Financing Administration is extending by two years the phase-in deadline for manufacturers to meet quality control requirements under the Clinical Laboratory Improvement Amendments of 1988, according to a final rule published in the Dec. 6 Federal Register. Under the rule, manufacturers of high- and moderate-complexity tests will have until Sept. 1, 1996 to either meet CLIA QC labeling requirements or have their labeling validated by FDA. The agency had been expected to complete its QC validation responsibilities by Sept. 1, 1994, but has been unable to do so because of a lack of resources