FDA revamps approval process for rad onc devices due to multiple errors
The letter, which was sent yesterday and signed by Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, told the manufacturers that analyses of medical device reports show that many problems with these devices are the result of design problems and could be fixed by incorporating additional safeguards.
According to Shuren, in the last 10 years the FDA has received reports of errors involving radiation devices, the most frequent of which were errors involving computer software uses, use of device and incorrect display. Of the devices involved in these error reports, linear accelerators accounted for 74 percent, radiation therapy treatment planning systems accounted for 19 percent, and ancillary devices (e.g., radiation therapy simulators) accounted for 7 percent.
Shuren also wrote that because of these error reports, the FDA may no longer allow the use of third party review in order to streamline the approval process.
In its letter, Shuren said the FDA plans to hold a public workshop on radiation therapy treatment planning, linear accelerators and ancillary devices. The topics will include:
- New safeguards and other special controls to improve safety;
- Possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and
- Premarket review of all modifications to software.
“FDA believes these steps and early communication between FDA and manufacturers will help mitigate current risks, including use errors, and reduce future risks associated with linear accelerators, radiation therapy treatment planning systems, and ancillary devices, and thereby result in saer and more effective radiation therapy,” wrote Shuren.