News | April 08, 2010

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

Related Content

Merit Medical Completes Acquisition of Cianna Medical
News | Women's Health | November 14, 2018
Disposable device manufacturer Merit Medical Systems Inc. announced the closing of a definitive merger agreement to...
Videos | ASTRO | November 08, 2018
ITN Editor Dave Fornell took a tour of some of the most innovative technologies on display on the expo floor at the 
The Fujifilm FCT Embrace CT System displayed for the first time at ASTRO 2018.
360 Photos | 360 View Photos | November 07, 2018
Fujifilm's first FDA-cleared compu...
This is the Siemens Magnetom Sola RT edition 1.5T MRI system optimized for radiation therapy displayed for the first time since gaining FDA clearance in 2018. It was displayed at the American Society for Radiotherapy and Oncology (ASTRO) 2018 annual meeting. Read more about this system at ASTRO 2018. #ASTRO18 #ASTRO2018
360 Photos | 360 View Photos | November 07, 2018
This is the Siemens Magnetom Sola RT edition 1.5T MRI system optimized for...
GE Healthcare Discovery RF Gen 2 system displayed at ASTRO 2018. It is a dedicated computed tomography (CT) scanner for radiation oncology
360 Photos | 360 View Photos | November 07, 2018
This is the GE Healthcare Discovery RF Gen 2 system displayed at the ...
Proton Therapy for Pediatric Brain Tumors Has Favorable Cognitive Outcomes
News | Proton Therapy | November 06, 2018
Proton therapy treatment for pediatric brain tumor patients is associated with better neurocognitive outcomes compared...
Videos | Radiation Oncology | November 06, 2018
Genomics can be used to assess a patient's radiosensitivity, which can be used to increase or decrease the radiation
150-Year-Old Drug Might Improve Radiation Therapy for Cancer
News | Radiation Therapy | November 02, 2018
November 2, 2018 — A drug first identified 150 years ago and used as a smooth-muscle relaxant might make tumors more