Proposed Rule
11 Jun 2025
regulation, fda, medical devices, diagnostics, packaging and containers, oncology, blood, hematology
🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
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.
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