CDRH Industry: Class II Special Controls Guideline - John Cunningham Virus Serological Reagents

A Class II Special Controls Guideline about John Cunningham Virus Serological Reagents has recently been posted.  This document was developed to support the classification of the John Cunningham Virus (JCV) serological reagents for the risk stratification for progressive multifocal leukoencephalopathy (PML) development into class II (special controls).