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Closing soon Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2025-N-1243

FDA reclassifies ISH test systems for oncology therapeutics from Class III to Class II

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  1. Related document

    Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product

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High FDA

FDA reclassifies ISH test systems for oncology therapeutics from Class III to Class II

The change lowers regulatory burden for companion diagnostic ISH tests while maintaining safety and effectiveness through special controls. The FDA has issued a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic...

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Health and Human Services Department, Food and Drug Administration · Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product · Aug 17