FDA’s Regulation of Analyte-Specific Reagents

February 1, 2003

One of the most confusing areas of FDA regulation surrounds the requirements governing analyte-specific reagents (ASRs). ASRs are raw materials and components used to develop laboratory assays. This article will provide a brief background on FDA’s regulation of ASRs, summarizing the key ASR requirements and addressing some common misconceptions and pitfalls in this area.