title: Nuclear Regulatory Commission regulatory status of approved intravascular brachytherapy systems.
abstract: OBJECTIVE
  To review current and potential future regulatory status of intravascular brachytherapy (IVB) systems.
  
  
  METHODS
  There are three approved IVB systems; two commercial IVBs are hand-operated manual devices; the third is remotely operated. In three Guidances, the Nuclear Regulatory Commission (NRC) applied certain regulatory concepts applicable to remotely operated high dose rate (HDR) afterloaders to manually operated IVBs. This article reviews these Guidances, newly released NRC regulations on the medical use of by-product material, and potential regulatory issues related to IVB systems.
  
  
  RESULTS
  The Guidances are specific. However, newly released NRC regulations on the medical use of byproduct material, including HDR afterloaders, omit IVB systems as a category. NRC licensure of IVB systems is considered case-by-case.
  
  
  CONCLUSIONS
  The current limited application of regulations applicable to HDR remote afterloaders to hand-held IVB systems could lead to other HDR-like regulations for hand-held IVB systems in future regulations.
authors.affiliation: Department of Radiation Oncology, Loyola University Chicago, 2160 S. First Avenue, Maywood, IL 60153, USA. gglasgo@lumc.edu
authors.forename: Glenn P
authors.initials: GP
authors.lastname: Glasgow
mesh_terms: D001918:Brachytherapy / Q000592:standards* / Q000639:trends; D023903:Coronary Restenosis / Q000532:radiotherapy; D006801:Humans; D011787:Quality of Health Care / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D011868:Radioisotopes / Q000008:administration & dosage / Q000592:standards; D011879:Radiotherapy Dosage / Q000592:standards; D014481:United States
chemical_list: D011868:Radioisotopes