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Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product | Sporos

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Proposed RuleRequest for Comment

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) 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.

Published

Jun 11, 2025

Comments Close

Aug 11, 2025

Citation

90 FR 24540

Agencies

2025-10549Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product

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Agencies (2)

FDA — Food and Drug Administration

HHS — Health and Human Services Department

Topics

Blood Medical devices Packaging and containers

Docket IDs

Docket No. FDA-2025-N-1243

CFR References

21 CFR 864

Document Details

Type: Proposed Rule
Action: Proposed amendment; proposed order; request for comments.
Document #: 2025-10549
Citation: 90 FR 24540
Publication Date: Jun 11, 2025
Dates: Either electronic or written comments on the proposed order must be submitted by August 11, 2025. Please see section X of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
Federal Register Pages: Vol. 90, pp. 24540–24549
Page Views: 1,157

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