Local, State, Federal

FDA Reviewing Linear Accelerator 510(k) Approval Process

On April 8, 2010, Jeffrey Shuren, MD, JD, director for the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), sent an official letter to all manufacturers of linear accelerators, radiation therapy treatment planning systems, and ancillary devices. The message was essentially this: ?We need to review and slow down the 510(k) approval process.?

Specifically, Shuren?s letter stated, ?In order to reduce the number of under-doses, over-doses, and misaligned exposures from therapeutic radiation, the FDA is taking several steps to improve the safety and safe use of certain radiation therapy devices.?

Given the negative oncology radiation media reports over the past 9 months, it isn?t surprising that the FDA would be acting in some capacity to address the reports. However, the letter was not written purely out of public pressure, but also due to some recent FDA data.

The FDA reviewed the Medical Device Reports (MDRs) related to linear accelerators. All hospitals must submit such reports to the FDA whenever there is any type of medical device failure or error that causes serious injury or death. The results from the MDR data mining reflected the concern from the recent news reports.

According to Shuren?s letter, between the last day of 1999 and February 18, 2010, ?FDA received 1,182 MDRs associated with the use of radiation therapy devices. Of these MDRs, linear accelerators accounted for 74%, radiation therapy treatment planning systems (RTP) accounted for 19%, and ancillary devices (eg, radiation therapy simulators) accounted for 7%. The most frequently reported device problems were computer software issues, use of device, and incorrect display. . . . A separate analysis of these MDRs for software problems identified 362 MDRs. Of these MDRs, linear accelerators accounted for 66%, RTP accounted for 29%, and ancillary devices accounted for 5%.?

Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics at the FDA, said the data indicated that the external 510(k) device approval process needed review.

Since the 1990s, manufacturers have been able to use FDA-approved third-party companies to review medical devices and software applications. These external reviewers are supposed to have the exact same device review process as the FDA, thus enabling a higher volume of 510(k) approvals and alleviating FDA backlogs. Once the application is completed, the external reviewer submits it to the FDA internal reviewers, who determine whether the review was done correctly and confirm the external reviewer?s recommendation. However, the FDA?s policy gave these internal reviewers only 15 days to go over the external review.

Gutierrez said, ?Some of those files are very, very big. So, within 15 days, a reviewer really can?t look through the whole file to make sure that the external reviewer has caught everything.?

For now, the solution is to suspend the external 510(k) review program and the FDA?s 15-day internal review constraints.

Second, the FDA will be holding a public meeting with manufacturers sometime in June. Topics to be discussed will include new safeguards and other special controls to improve safety, possible changes in premarket device and software testing, and a premarket review of all modifications to software.

?I expect that this is a collaborative process,? said Gutierrez of the upcoming June meeting. ?I think manufacturers do take this issue seriously. Typically, at meetings like this where they publicly hear what kind of things can be done from the FDA, they themselves bring ideas to the table. And then we?ll move from there.?

?Tor Valenza