Federal Register #2026-16727

FDA Reclassifies In Situ Hybridization Test Systems for Oncology Therapeutics

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is reclassifying in situ hybridization (ISH) test systems for oncology therapeutics. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - Products/Services Requested: - In situ hybridization (ISH) test systems for use with approved oncology therapeutic products - Product codes: NYQ, MVD, OWE, PNK - No specific part numbers or quantities provided - OEMs and Vendors: - No specific OEMs or vendors named - Unique/Notable Requirements: - Devices reclassified from class III (premarket approval) to class II (special controls) - Special controls include design verification, validation, labeling, and performance data requirements - Manufacturers may now submit 510(k) premarket notifications instead of PMAs, enabling faster market access - Regulatory focus on safety and effectiveness for ISH-based oncology diagnostic devices

Description

This procurement involves the reclassification of specific in situ hybridization (ISH) test systems used with oncology therapeutic products, as finalized by the FDA. The FDA is issuing a final order reclassifying these ISH test systems from class III (premarket approval) to class II (special controls), subject to premarket notification. The order establishes a new device classification regulation and special controls to ensure the safety and effectiveness of these devices. The final order is effective September 16, 2026.

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