Federal Register #NRC-2025-1237

NRC Proposed Rule to Modernize Medical Use Licensing for Byproduct Material

The U.S. Nuclear Regulatory Commission (NRC) is proposing regulatory changes to modernize and streamline medical use licensing of byproduct material: - Government Buyer: - U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Material Safety and Safeguards - OEMs and Vendors: - No specific OEMs or vendors are named, but the rule directly impacts manufacturers of rubidium-82 generators, microsource brachytherapy devices, and other emerging medical technologies - Products/Services Requested: - Rubidium-82 Generators (positron-emitting radiopharmaceutical generators for cardiac imaging) - Emerging Medical Technologies (EMTs), including gamma stereotactic radiosurgery devices, ophthalmic source/applicator devices, generators, and microsources - Microsource Brachytherapy (inert solid microspheres or microparticles containing radioactive material) - Diagnostic Sodium Iodide I-131 (regulatory changes for diagnostic use) - Unique or Notable Requirements: - Expands physician eligibility to include foreign-trained individuals licensed in the U.S. - Revises training and experience requirements to be more flexible and performance-based - Codifies licensing pathways and safety criteria for emerging medical technologies - Updates regulations for rubidium-82 generators - Removes written directive requirement for diagnostic sodium iodide I-131 - Reduces event reporting and recordkeeping burdens - Focuses on supporting innovation while maintaining safety standards

Description

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to reduce barriers to medical use licensing. The proposed rule aims to reduce overly prescriptive regulations, increase flexibility, modernize radiation safety practices for the medical use of byproduct material, enable more efficient and predictable licensing for emerging medical technologies, and reduce unnecessary burdens in training and experience requirements for medical authorized users. The NRC is also revising guidance for this proposed rule and will incorporate minor editorial corrections. Comments on the proposed rule must be submitted electronically by September 10, 2026.

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