Much Ado About Nothing? Weighing The Impact Of The Institute of Medicine's 510(k) Report

Article preview from IN VIVO - September 1, 2011

Industry and regulators eagerly awaited the Institute of Medicine's 510(k) report, anticipating it could have a major impact on reforming this regulatory path. The result, however, has been one nobody expected: device companies and the FDA united in support of the current program.

Much Ado About Nothing? Weighing The Impact Of The Institute of Medicine's 510(k) Report

Article preview from IN VIVO - September 1, 2011

Late this summer, a panel of experts from one of the most esteemed research institutions, charged with reviewing the process by which most medical devices come to market, made a startling recommendation: the 510(k) program, not fit for its designated purpose, should be replaced by FDA and Congress. The report, issued July 29 by the Institute of Medicine, came as a shock to many, to say the least. After all, about a third of new devices each year reach the US market via the 510(k) pathway. FDA has been working intently over the past year or so to make reforms to the 510(k) program to address its shortcomings. Industry has been engaging on every detail, and pushing back on the most controversial ones. But one thing that has not been on the table: getting rid of the 35-year-old program and starting over. That is the last thing companies want because they prefer the devil known to a new, untested process that brings with it the likelihood for even less predictability than the current program. For an influential group like the IOM to come to the conclusion that the efforts to reform the existing program weren't worth the time could have dealt a major blow to industry's efforts to improve the certainty and transparency of the 510(k) process.

But it hasn't happened, at least not yet. And perhaps most surprising is that the IOM report has succeeded in doing what few thought possible – bringing industry and regulators together in support of the current program.

After the months of anticipation, all of the buzz surrounding the release of the IOM report may amount to much ado about nothing. FDA quickly disavowed the report's primary recommendation, and the response from Congress has been muted. Even members of the IOM committee that prepared the report appear to be downplaying some of its concerns during public discussions since the report's release. To be sure, some in the medical and policy communities are pressing for the recommendations to be taken more seriously. But the prevailing feeling among industry and other experts is that it may not have much impact at all.

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