Medical Devices; Radiology Devices; Classification of Blood Irradiators

Document 2026-05320 is a Proposed Rule published by the Department of Health and Human Services in the Federal Register on March 18, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators.

No. Document 2026-05320 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.