US FDA’s 510(k) Under Fire

Is US FDA’s 510(k) process hazardous to your health? Yes, says a five-year study published in the Archives of Internal Medicine, which reports that more than 70% of recalled devices were cleared for market under the protocol. Nonsense, replies US industry association AdvaMed, which points the finger at a deeply flawed analysis.

Medical device companies have stretched the notion of “similar” [as defined by the 510(k) review process] far beyond regulators’ intention when the law went on the books in 1976, Diana Zuckerman, one of the study’s co-authors, told the Los Angeles Times. “The law has gotten looser and looser over time.”

There is a problem all right, replies AdvaMed, but if anything is loose it is the report’s methodology.

“Simply put, this paper is seriously flawed and inconsistent with three previous analyses of the same data set conducted by respected researchers,” writes Stephen J. Ubl, Advamed President and CEO in a press release about the medical device recalls. “Because of an elementary error in data analysis, the conclusions drawn from the study are faulty, and the paper is marked by a large number of factual errors and misleading inferences.” Ubl noted that, “three recent studies have all found that the 510(k) process has a remarkable safety record with extremely low recall rates—one study reported a rate of less than two-tenths of one percent.”

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Tags: 510(k), FDA, medical device recall, recall