For those of you who may not be aware, the FDA has published its final rule on IHC antibodies and reagents. Those of least risk that are used adjunctive to diagnosis have been downclassified as Class I devices, not subject to FDA review prior to marketing. ER/PR reagents, among others, have been downclassified to Class II devices. Although the final rule still needs a bit more comprehensive review, all-in-all this may be good news for maintaining availability of IHC reagents. A copy of the rule, published in the Federal Register on 6/3/98 (page 30132), is available from the Federal Register web site and the FDA web site. JCIM will also likely publish a summary of the rule in the near future at http://www.jcim.org.