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IMMUNOHISTOCHEMICAL PRODUCTS WOULD BE CLASS I FOR LOWEST-RISK ADJUNCTIVE USES UNDER FDA PROPOSED REGULATION; ALL IHCs WOULD NEED PREMARKET REVIEW

This article was originally published in The Gray Sheet

Executive Summary

FDA's classification proposal for immunohistochemistry (IHC) reagents and kits would place the products in either Class I, Class II, or Class III depending on the degree to which the test is relied upon to make a diagnostic decision. The proposed regulation, published in the June 14 Federal Register, marks a departure from a previous agency plan endorsed by FDA's Hematology and Pathology Devices Panel in 1994 that would have regulated all IHC devices as Class II products.
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