Federal Register: final rule
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Federal Register published "Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product" on 2026-08-17. First seen on Kresmion 2026-10-26 18:24 UTC.
The record
- Publisher
- Federal Register
- Agency
- Health and Human Services Department; Food and Drug Administration
- Source
- Federal Register
- Kind
- Federal Register: final rule
- Jurisdiction
- United States
- Topics
- Health
- Importance
- Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields
- Published (source time)
- 2026-08-17 (the source gives a date only)
- First seen on Kresmion
- 2026-10-26 18:24 UTC
The original
Open the original on www.federalregister.govLink not checked yet: one check due 2026-11-25 (the source published this record more than 7 days before Kresmion first saw it).
Source: Federal Register (federalregister.gov). U.S. government work, public domain.
The publisher's summary
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.
The publisher's words, as published.
Federal Register document
- Document number
- 2026-16727
- Document type
- Rule
- Status
- Published
Cite this data
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Upstream: Federal Register
Kresmion, "Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product", data as of 2026-08-17, https://kresmion.com/record/1521. Upstream data: Federal Register.
Link to this data (HTML):
<a href="https://kresmion.com/record/1521">Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product (Kresmion)</a>