Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Improving radiation therapy dosing: FDA is holding a public meeting June 9 and 10 in Gaithersburg, Md., to discuss steps that makers of radiotherapy equipment - including linear accelerators, radiation therapy treatment planning systems and radiation therapy simulators - can take to reduce under- and overdosing and misaligned radiation exposures. FDA says it is rethinking pre-market approval requirements for such devices (1"The Gray Sheet" April 12, 2010). The first day of the workshop will focus on equipment features that should be incorporated into devices and software, and day two will focus on improving user training and quality assurance at medical facilities. FDA is accepting comments by May 15 in response to questions on device safeguards, facility reporting, training and quality assurance posted in a May 7 Federal Register 2notice. A related FDA initiative is addressing radiation overexposure in medical imaging procedures (3"The Gray Sheet" Feb. 15, 2010)