CLIA
This article was originally published in The Gray Sheet
Executive Summary
The Centers for Disease Control and Prevention currently is informally assisting FDA in determining complexity categorizations under the Clinical Laboratory Improvements Amendments of 1988 for new in vitro tests and also is sending out notification letters to manufacturers. CDC was to take on sole responsibility from FDA for the categorizations on Sept. 1, but the Office of Management and Budget raised concerns with the switch ("The Gray Sheet" Sept. 12, p. 5). CDC is helping to eliminate the backlog of tests needing categorization in preparation for its possible assumption of the responsibilities. HHS also is still working out how to address the problem of FDA's inability to undertake its CLIA quality control labeling review responsibilities due to a lack of resources. The Health Care Financing Administration is expected to publish a notice extending the Sept. 1 deadline by which all in vitro test labeling was supposed to conform with CLIA QC requirements; HCFA has said it will not enforce the requirements before the extension is published