Medical Devices; Radiology Devices; Classification of Blood Irradiators Regulatory Impact Analysis; Proposed Rule

The proposed rule, if finalized, would classify blood irradiator devices (unclassified, preamendments devices) into two classes based on intended use. It would classify blood irradiator devices intended to irradiate blood or blood products to prevent transfusion-associated graft versus host disease (blood irradiators intended to prevent TA-GVHD) into class II (special controls) and blood irradiator devices intended to irradiate intra-operatively salvaged blood in cancer patients undergoing surgery to prevent metastasis (blood irradiators intended to prevent metastasis) into class III (premarket approval). Separately, FDA also is issuing a proposed order requiring the filing of a premarket approval application (PMA) for blood irradiators intended to prevent metastasis. Quantified benefits of the proposed rule, if finalized, would consist of cost savings to industry and FDA from a reduction in the quantity and time burden of informal inquiries related to blood irradiators intended to prevent TA-GVHD. We also estimate cost savings to industry and FDA from a reduction in the number of premarket notification (510(k)) submissions necessitating requests for additional information from FDA before and during review. Industry and FDA could incur costs associated with premarket approval for current and future blood irradiators intended to prevent metastasis. We additionally quantify one-time costs to industry to read and understand the proposed rule and the proposed order requiring the filing of a PMA, as well as one-time costs to industry to revise labeling. We estimate that the annualized benefits over 10 years would range from $84 to $180,268 at a 7 percent discount rate, with a primary estimate of $90,176, and from $86 to $184,271 at a 3 percent discount rate, with a primary estimate of $92,178. The annualized costs would range from $0.68 million to $1.51 million at a 7 percent discount rate, with a primary estimate of $1.07 million, and from $0.66 million to $1.53 million at a 3 percent discount rate, with a primary estimate of $1.07 million.

Regulatory Impact Analysis

Medical Devices; Radiology Devices; Classification of Blood Irradiators RIA; Proposed Rule (PDF- 0.1MB)

Federal Register: 91 FR 12951
Publication Date: 03/18/2026
Docket: FDA-2025-N-5996