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

Open for public comment until Jan. 11, 2027. Comment on Regulations.gov

What it does

The Food and Drug Administration (FDA) is proposing to reclassify immunohistochemistry (IHC) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes MVC, NKF, QQT, NQF, PLS, PKW, QUL, QNH, QZJ, SBL, SER, and SHF), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is proposing minor revisions to an existing classification regulation and 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 these devices.

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

What it would change

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

21 CFR 864

What happens next and when

Either electronic or written comments on the proposed order must be submitted by January 11, 2027. Please see section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Title 21 on eCFR

The record as published

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