Medical devices and the US Food and Drug Administration: regulating the tools of radiology.
The radiology community has an ever-expanding array of technologies to use in the care of patients. Regulated by the US Food and Drug Administration, these technologies often raise complex regulatory and legal questions in everyday practice that can be daunting for practicing radiologists. This article reviews the federal medical device regulatory framework pertinent to the practice of radiology, with the aims of highlighting the potential impact of federal regulation on everyday practice and minimizing misunderstandings about enforcement exposure.
Henderson
Jennifer A
JA
Center for Integration of Medicine and Innovative Technology, Cambridge, Massachusetts 02139, USA. jahenderson@partners.org
Smith
John J
JJ
D003257:Consumer Product Safety; D019719:Diagnostic Equipment / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D011871:Radiology / Q000295:instrumentation* / Q000592:standards; D017751:Safety Management; D013679:Technology, Radiologic / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*