Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The U.S. FDA has issued a final order reclassifying in situ hybridization (ISH) test systems used with approved oncology therapeutic products from class III to class II devices. This reclassification applies to product codes NYQ, MVD, OWE, and PNK, making them subject to premarket notification. Additionally, the agency is establishing a new device classification regulation along with required special controls.
Original source: Federal Register — FDA Documents — 2026-08-17T04:00:00+00:00
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