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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 Stuff: Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP), and Cardiac C-Reactive Protein (cCRP) Assays (1), the discussion on indications for use can be found in section 5: Types of CRP Assays. This section states that, although all CRP assays start with the same basic indications for use (i.e., general evaluation of infection, tissue injury, and inflammatory disorders), hsCRP assays and cCRP assays have additional claims.
hsCRP assays are intended for more sensitive detection of inflammatory states, whereas cCRP assays are intended for use in cardiovascular risk assessment. FDA data requirements differ for each of these 2 intended uses. The regulatory distinctions in both claims and data requirements have been established to assist manufacturers, FDA staff, and laboratory users to understand the different...