Clinical Chemistry
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Clinical Chemistry 52: 1256-1257, 2006; 10.1373/clinchem.2006.072009
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(Clinical Chemistry. 2006;52:1256-1257.)
© 2006 American Association for Clinical Chemistry, Inc.

Point/Counterpoint

Counterpoint: Food and Drug Administration Guidance for C-Reactive Protein Assays: Matching Claims with Performance Data

James V. Callaghana and Steven I. Gutman

1 Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD.

aAddress correspondence to this author at: Food and Drug Administration, 2098 Gaither Road, HFZ-440, Rockville, MD 20850. Fax 240-276-0652; e-mail james.callaghan@fda.hhs.gov.

The first 20% of the full text of this article appears below.

Dr. Rifai and coauthors seem to have misunderstood the guidance proffered by the US Food and Drug Administration (FDA)1 and the laboratory safety tip addressing the issue of matching claims with performance data for C-reactive protein (CRP) assays. The FDA believes that different claims for CRP require very different data sets and different performance criteria to support differing intended uses.

FDA premarket guidance proposals are written to benefit companies and FDA reviewers regarding recommendations for studies that support premarket submissions for medical devices in the United States. They are not meant to be clinical practice guidelines; however, FDA guidelines are meant to be based on sound science, committed to truth in labeling, and intended to help to ensure the safety and effectiveness of medical devices for the promotion of public health.

The driving force behind FDA premarket assay reviews is based on the indications for use of a given assay. For regulatory purposes, the distinction between CRP assays, high-sensitivity (hs)CRP assays, and cardiac (c)CRP assays lies with the Indications for Use. In the Guidance for Industry and FDA Staff: Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive . . . [Full Text of this Article]




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M. Helfand, D. I. Buckley, M. Freeman, R. Fu, K. Rogers, C. Fleming, and L. L. Humphrey
Emerging Risk Factors for Coronary Heart Disease: A Summary of Systematic Reviews Conducted for the U.S. Preventive Services Task Force
Ann Intern Med, October 6, 2009; 151(7): 496 - 507.
[Abstract] [Full Text] [PDF]


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