FDA Develops Device Panel

April 2006

Following a recommendation Guidant received last month, the Food and Drug Administration (FDA) is appointing outside medical experts to help review the heart defibrillators and pace makers.

This is the first time the FDA will have outside experts advising them about the safety of medical devices on the market. Usually, the FDA looks to its own advisory panel to decide whether a device should be sold. The experts will help the FDA interpret data from device manufacturers and will also advise the agency about how to properly respond to immediate problems.

Seven known patients died when a Guidant defibrillator short-circuited. The number of deaths could be higher, but doctors were alerted only recently.

The FDA plans to appoint experts in the next few months and hopes that the process will be complete by October.

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