Home › Recently closed › 2026-05320
Medical Devices; Radiology Devices; Classification of Blood Irradiators
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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.
- Document type
- Proposed Rule
- Federal Register document number
- 2026-05320
- Published
- Mar 18, 2026
- Action
- Proposed rule.
- Docket
- FDA-2025-N-5996
- Comments posted on Regulations.gov (at last check)
- 5
- RIN
- 0910-AI93
- CFR parts
- 21 CFR 892
- DATES section (from the document)
- Either electronic or written comments on the proposed rule must be submitted by May 18, 2026.
- Topics (auto-tagged)
- Vaccines / biologics Medical devices
Source: Federal Register API, document 2026-05320. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.