Reclassification of in vitro diagnostics (IVD) proposed
This article was originally published in Clinica
Executive Summary
Immunohistochemistry reagents and kits which provide adjunctive diagnostic information not ordinarily reported to the clinician as an independent finding would be categorised as Class I devices under a proposed US rule published this month. The US FDA plans to place those ICHs which provide information for significant medical decisions independent of other pathological tests in Class II.