Medical Devices

IOM report on FDA device review is challenged even before release

Institute of MedicineEven before the Institute of Medicine’s much-anticipated report on the 510(k) device review process at the U.S. Food and Drug Administration is released, medical device industry proponents are trying to undermine it, reports The New York Times.

The article focuses on the efforts of Ralph Hall, a professor of law at the University of Minnesota, and the Washington Legal Foundation who have been critical of the selection of the IOM panel. They argue that the panel does not have any industry, investment community or patient representation.

The IOM report will be released Friday.

The device industry believes that the IOM report could make it tougher to get products through the FDA and has fought hard to show that products are safe and do not need additional scrutiny. Several industry-affiliated studies have been critical of the FDA describing the agency as being slow, opaque and hard to predict, thereby hurting innovation and the global competitiveness of the U.S. medical device industry.


Hall, who has experience as a lawyer for the medical device industry, authored a report last year that called into question the very need for tougher regulation.  He found that  between 2003 and 2009, the recall rate of Class I recalls of 510(k)-approved products out of a five-year average of overall 510(k) submissions was a tiny 0.45 percent.

In other words, concern that the FDA is approving unsafe products is patently wrong.

However, the same data showed that when comparing Class I recalls of 510(k)-approved products with total Class I recalls, the recall rate was much higher at 75.4 percent.

The New York Times story draws attention to the fact that Hall, in his efforts to counter the pending IOM report, authored a report earlier this year that argued that “in selecting its panel, had violated a little-known rule, the Federal Advisory Committee Act, which requires balance on such committees.”

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