SOURCE-LINKED INTELLIGENCE
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 to provide a reasonable assurance of safety and effectiveness of this device type.
Read original source ↗ Open in workspace
- recordType
- article
- region
- US
Evidence & attribution
- US Federal Register · 2026-08-17T00:00:00.000Z
First collected: 2026-09-19T20:28:14.107Z. This is not the publication date.