Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
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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.
- Tags
- health IT, Rule, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISM 3: Information Security Program; CISM 4: Incident Management; CISA 1: Information System Auditing Process
- Source record id
- 2026-16727
- First seen by InfoSec Signals
- Sep 23, 2026
Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration about this source more from it
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