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

Abstract

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 …