IVD compliance policy guide should deem "experimental use" products unregulated -- JCIM petition.
This article was originally published in The Gray Sheet
Executive Summary
IVD COMPLIANCE POLICY GUIDE: "EXPERIMENTAL USE ONLY" PRODUCTS should be recognized as an unregulated category in the FDA's CPG on commercialization of unapproved in vitro diagnostics, the Joint Council of Immunohistochemical Manufacturers states in a May 14 petition submitted to FDA. "The CPG's failure to acknowledge that this category of products exists and that they should be unregulated has created confusion among the research community and raised the specter of regulating pure research materials," JCIM claims.