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.

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