Rad therapy groups support FDA review

Apr 12, 2010

The American Society for Radiation Oncology (ASTRO) and the two major trade associations representing manufacturers of diagnostic imaging and radiation oncology equipment have issued statements supporting the U.S. Food and Drug Administration's (FDA) new initiative to improve the safety of radiation therapy devices.

A letter sent to 93 companies on April 8 by Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, stated that the FDA was examining whether it would continue to allow third-party regulatory review of radiation therapy devices. The letter said that third-party review might not be appropriate, noting that the agency had received 1,182 medical device reports associated with the use of radiation therapy devices over the past decade.

The letter also announced that the FDA would hold a public workshop in the near future to discuss the topics of new safeguards and controls to improve changes, changes in premarket device testing with an emphasis on software, and premarket review of all modifications to software.

ASTRO's chairman, Dr. Tim R. Williams, said that the Fairfax, VA-based organization supports the 510(k) clearance process but urges that appropriate safeguards be implemented to ensure that new technology is safe and effective.

Williams also said that "ASTRO agrees that quality concerns with the third-party review program should be addressed and that the FDA must ensure that third-party reviewers have not only the appropriate expertise, but also the necessary information to conduct a thorough review."

Both the Advanced Medical Technology Association (AdvaMed) of Washington, DC, and the Medical Imaging and Technology Alliance (MITA) of Arlington, VA, issued similar statements of support. Dave Fisher, MITA's executive director, supported the idea of a workshop, commenting that "solutions to mitigate any incidents or potential incidents must involve the entire medical community."

David Nexon, senior executive vice president of AdvaMed, pointed out that according to ASTRO's estimates, 99.99% of radiotherapy treatments occur without incident, but that "any incident in which a patient receives an inappropriate radiation dose is one incident too many."

FDA hearings rise above medical radiation rhetoric, March 31, 2010