Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
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 t
Record details
Published: 15 August 2026
Source: US Federal Register
Category: Policy
Topics: Regulation · Healthcare
Retrieved: 15 August 2026
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ethics.ai (15 August 2026), “Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product,” evidence record 19535, https://ethics.ai/record/19535 (originally published by US Federal Register).
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