Federal Register #2026-23005

FDA proposes class II reclassification for oncology-related IHC test systems

The U.S. Food and Drug Administration (FDA) is proposing a regulatory change for oncology-related immunohistochemistry (IHC) test systems, not seeking to purchase goods or services. - Government agency: U.S. Department of Health and Human Services, through the FDA. - Proposed action: Reclassify IHC test systems used with corresponding approved oncology therapies from class III (premarket approval) to class II (premarket notification and special controls). - Scope: Current and future oncology therapeutic IHC-based test systems under product codes MVC, NKF, QQT, NQF, PLS, PKW, QUL, QNH, QZJ, SBL, SER, and SHF. - OEMs and product examples named: Dako and DakoCytomation (including HercepTest, PATHWAY HER2, and EGFR pharmDx); Ventana Medical Systems; BioGenex; and Bond/Oracle, including referenced PD-L1 assays. - Notable requirements: If finalized, manufacturers would generally submit a 510(k) premarket notification and meet special controls addressing device safety and performance. - Procurement status: No products or services, quantities, part numbers, or contract value are requested; this is a proposed regulatory action.

Description

The FDA proposes to reclassify immunohistochemistry test systems used with corresponding approved oncology therapeutic products from class III (premarket approval) to class II (special controls), subject to premarket notification. The proposal covers the listed product codes and applies to current and future oncology therapeutic IHC-based test systems. It includes minor revisions to an existing classification regulation and a new device classification regulation with special controls intended to provide reasonable assurance of safety and effectiveness. Comments are due January 11, 2027.

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