Medical Devices; Radiology Devices; Classification of Blood Irradiators

What it does

The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.

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 892

Before this

No earlier Federal Register document under regulation identifier 0910-AI93 since Jan. 1, 2025.

What happens next and when

Either electronic or written comments on the proposed rule must be submitted by May 18, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2025-N-5996 on Regulations.gov
• Title 21 on eCFR

The record as published

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