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

What it does

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 Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 864

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This order is effective September 16, 2026. See further discussion in section IV, "Implementation Strategy."

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2025-N-1243 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register