TABLE 2-1Comparison of CLIA and FDA Regulatory Pathways

CLIAFDA
Research PhaseNoYes
Analytical ValidationPost hoc samplingYes
Clinical ValidationNoYes
Report Adverse EventsNo requirement; no systemYes
Transparent ResultsNo public informationPublished review summary

NOTE: CLIA, Clinical Laboratory Improvement Amendments; FDA, U.S. Food and Drug Administration.

SOURCE: Gutierrez, IOM workshop presentation on November 15, 2011.

From: 2, Calls for Change

Cover of Genome-Based Diagnostics
Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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