FDA bolsters process for OK’ing radiation devices
In the wake of recent safety problems, the Food and Drug Administration has announced plans to strengthen its approval process for radiation therapy equipment (April 5, p. 14). The new, more rigorous standards were alluded to in a letter to radiation device manufacturers from Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. In the letter, Shuren attributed many of the reported problems associated with radiation therapy to a lack of adequate safety measures. The FDA arrived at its conclusions using data from more than 1,100 medical-device reports, which are used to describe adverse events. More information regarding specific changes to approval protocol, premarket testing and review will follow in an official notice, the agency said. Additionally, the FDA plans to hold a public workshop where manufacturers can learn more about the changes.