Regulatory Counsel

0910-AI93 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Radiology Devices; Classification of Blood Irradiators

FDA is proposing to classify two types of blood irradiators, which are unclassified preamendments devices, based on intended use. Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Not subject to, not significant 21 CFR 892.7000 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 371 No NPRM 03/18/2026 91 FR 12951 NPRM Comment Period End 05/18/2026 Final Rule 02/00/2027 No No None No No No No Patricia Kaufman Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-1174 patricia.kaufman@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Silver Spring MD 20993