FDA Eliminates Third Party Approval of Radiotherapy Devices

April 9, 2010 - The U.S. Food and Drug Administration (FDA) will no longer allow a third party review process on new radiotherapy equipment.
The announcement came in a letter the FDA sent to 93 makers of radiation treatment devices, urging them to attend a workshop to address concerns about patient exposure to excess radiation from medical treatments and procedures.

Companies sent letters include Varian Medical Systems, Siemens, Philips, GE Healthcare, Hitachi and several private firms.

The approval process had been designed to reduce the agency’s workload and streamline approval time. Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health, said it based its decision on the analysis of more than 1,000 reports on medical errors involving radiation therapy devices filed over the last 10 years.
An estimated 74 percent involved linear accelerators, and the errors stemmed mainly from computer software, according to Shuren. He said safety regulations could mitigates errors resulting from faulty design or use error.

For more information: www.fda.gov and www.acr.org