The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
US Federal Register - FDA Rules · August 17, 2026
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
FDA reclassifies in situ hybridization test systems for oncology therapeutics from class III to class II, establishing special controls and premarket notification requirements.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.