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HHS/FDA RIN: 0910-AI93 Publication ID: Spring 2024 
Title: ●Radiology Devices; Classification of Blood Irradiator Devices 
Abstract:

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 into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 892.7000   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2025 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Patricia Kaufman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66,
Silver Spring, MD 20993
Phone:301 796-1174
Email: patricia.kaufman@fda.hhs.gov