Health Law Daily Wrap Up, MEDICAL DEVICES—PROPOSED RULES: Classification of blood irradiators proposed, (Mar 23, 2026)

By WK Editorial Staff

The proposed classification action classifies blood irradiators intended to prevent TA–GVHD into class II as well as establish the special controls necessary to provide reasonable assurance of the safety and effectiveness of these devices.

The FDA classify blood irradiator devices, which are unclassified, preamendments devices, into two classes based on intended use. The FDA would classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graftversus-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 (Proposed rule, 91 Fed. Reg. 12951 (Mar. 18, 2026)).

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

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