April 21, 2004

Defibrillator Maker claims FDA warnings about quality don't relate to usability, safety or efficacy

A statement in a short Reuters article (Cardiac Science Gets FDA Warning on Quality) struck me as a good example of a corporate PR group trying to spin bad press. Here's an excerpt (emphasis is mine):

"Cardiac Science Inc., a defibrillator maker, said on Wednesday that it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing facility in Minneapolis, Minnesota. The FDA letter ... said certain procedural and documentation items in the company's quality system were not in compliance, the company said in a statement. The letter did not relate to the usability, safety or efficacy of the company's defibrillators, the firm said."

So what they are REALLY saying is the FDA warned them about problems with their quality process. The FDA didn't point out any exact issues with their products. Of course, the process is what leads to (i.e., designs, tests, and approves) the products, but that's just a minor point, right?

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