Consumers Groups Attack FDA Over De Novo Process

A group of 12 consumer groups is chastising the US Food and Drug Administration (FDA) for approving what they perceive to be 'high-risk' medical devices through FDA's de novo approval pathway.

In a letter to FDA Commissioner Margaret Hamburg sent 29 February, the groups, including Consumers Union and Public Citizen, said that FDA's use of the de novo pathway was setting a bad precedent.

"Medical devices intended to save lives should require FDA's most rigorous safety testing.  Bypassing such testing up front can put hundreds of thousands of patients at risk of serious harm, similar to what we have seen with recalled metal hips and surgical mesh," said Lisa McGiffert, director of Consumers Union's Safe Patient Project.

The de novo process is intended for moderate-risk devices with no marketed predicate to which it can claim substantial equivalence.

While the group said that it was fine with the de novo process in general-a stance also taken by the Institute of Medicine (IOM)-it believes that the pathway is approving riskier devices such as an endovascular suturing system manufactured by Aptus Endosystems Inc.

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