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

Document 2025-10549 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on June 11, 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type. View the original at https://www.federalregister.gov/documents/2025/06/11/2025-10549/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with.

No. Document 2025-10549 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.