FDA tightens rules on radiation-emitting therapeutic devices

April 8, 2010 by MassDevice staff

The Food & Drug Administration says it received nearly 1,200 reports involving radiation therapy used to fight cancer; FDA director of in vitro diagnostic device evaluation and safety Alberto Gutierrez says no new devices will be cleared using third-party reviewers or the special 510(k) process.

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The Food & Drug Administration is looking to cut down on the number of accidental radiation overdoses by changing the way new radiation-emitting therapies make it to market.

The federal watchdog agency sent out a letter to manufacturers today, reporting that it received 1,200 reports between 1999 and 2010 about devices that deliver radiation treatments to cancer patients.

"Analyses of Medical Device Reports (MDRs) revealed device problems that appear to be the result of faulty design or use error that could be mitigated by the incorporation of additional safeguards," the agency wrote.

Of the 1,200 reports, more than 74 percent of the incidents involved linear accelerators, computer-aided devices that deliver high-powered doses of radiation to destroy cancer cells.

The most frequently reported problems were "computer software issues, use of device, and incorrect display. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as 'unknown,'" according to the letter.

The FDA said it plans to hold a public hearing to address the issue and is advising companies that special 510(k) applications and third party-reviewed submissions might not be appropriate until they can iron out the problem.

In an interview with the New York Times, Dr. Alberto Gutierrez, the FDA's director of in vitro diagnostic device evaluation and safety, confirmed that the agency will no longer allow new radiation equipment to enter the market using the streamlined approach, as it has since the 1990s.

But Dick Thompson, a spokesmen for the FDA, told MassDevice that the agency is asking for companies to come to them to discuss the issue before making submissions on new products using a third-party reviewer.

When asked if this could be classified as a moratorium on third-party reviews for the devices, Thompson said it was more of a "change in practice."

About 40 percent of the radiation-emitting devices are cleared for market using the special 510(k) or a third-party review.