Data / Federal rules / 2026-05320
Medical Devices; Radiology Devices; Classification of Blood Irradiators
The Food and Drug Administration published this proposed rule in the Federal Register on March 18, 2026. Comments closed on May 18, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-05320
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 18, 2026
- Comments due
- May 18, 2026
- Dates
- Either electronic or written comments on the proposed rule must be submitted by May 18, 2026.
- Docket
- Docket No. FDA-2025-N-5996
- Regulation ID (RIN)
- 0910-AI93
- Code of Federal Regulations
- 21 CFR 892
- Topics
- Medical devices; Radiation protection; X-rays
- Pages
- 16
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on radiation protection · Rules on x-rays · Published in March 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.