Regulatory initiatives and framework in the USA: interventional radiology.
Therapeutic procedures using interventional radiology equipment as the imaging tool are often the only available treatment for serious, life-threatening conditions. Many of these procedures require extended periods of radiation exposure often at one location on the patient. As a result, the US Food and Drug Administration (FDA) continues to receive reports of radiation-induced injuries to the skin in patients undergoing some of these therapeutic procedures. The regulatory scheme applicable to interventional radiology equipment in the US is described including federal, state and local aspects, and the impact of professional and non-governmental organisations. Current activities within the FDA and other organisations which have or will affect the use, maintenance and manufacture of interventional radiology equipment are also described.
Gagne
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RM
Center for Devices and Radiological Health/FDA, 9200 Corporate Boulevard (HFZ-142), Rockville, Maryland 20850, USA. RMG@CDRH.FDA.Gov
Shope
T B
TB
D004869:Equipment Safety; D006801:Humans; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000209:etiology; D015641:Radiography, Interventional / Q000009:adverse effects / Q000295:instrumentation / Q000592:standards*; D015642:Radiology, Interventional / Q000331:legislation & jurisprudence* / Q000592:standards; D012867:Skin / Q000528:radiation effects; D014481:United States; D014486:United States Food and Drug Administration