In a recent letter to manufacturers, the Food and Drug Administration said the use of the third-party review alternative for certain radiation-therapy equipment undergoing the 510K approval process may not be appropriate given growing concerns over radiation-dose exposure.
The 510K review process is used to approve product updates and the production of an FDA-approved technology by a new manufacturer. But the agency, as a part of an ongoing effort to improve radiation safety and prevent under-dosing and overdosing of patients, is considering changes to both the premarket and 510K approval process for high-risk radiation devices.
The letter, signed by Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, was sent to manufacturers of linear-accelerator radiation machines, therapy-treatment planning systems and other high-risk ancillary devices. According to the letter, the FDA received nearly 1,200 reports between December 1999 and February 2010 detailing problems related to the use of such devices. Linear accelerators accounted for 74% of the reports, treatment planning systems for 19% and ancillary devices for 7%. Software issues, device-use problems and incorrect dosage display were the most frequently reported problems, said Shuren.
The agency also pressed manufacturers to investigate the cause of device-usage problems as a part of their Corrective and Preventative Actions. “FDA believes these steps and early communication between FDA and manufactures will help mitigate current risks, including use errors, and reduce future risks,” Shuren wrote.