New Report on FDA Regulation of Medical Devices Receiving Industry Pushback

By Mike Rozembajgier

A new Institute of Medicine report scheduled for release Friday is already receiving pushback from the medical device industry, according to a recent New York Times article.

The report, commissioned by the Food and Drug Administration (FDA), will likely propose tougher regulations for the FDA’s 510(k) approval process, under which 70 percent of the medical devices that have been recalled since 2005 were originally approved for sale. Devices approved through the 510(k) process that were later recalled include hip implants and joint replacements.

Meanwhile, device manufacturers have been busy producing their own reports claiming that any increase in regulation will slow the industry’s rate of innovation and possibly harm patients. Last month, the pro-business Washington Legal Foundation filed a petition with the FDA arguing that the  agency was legally barred from incorporating any of the report’s recommendations because the panel that produced was biased. According to the petition, the panel lacked industry officials, representatives from the investment community, and patients who had benefitted from the devices. In an interview with the Times, Richard A. Samp, a lawyer for the legal foundation, said “We wanted to let the FDA know that there were significant concerns with the composition of the committee”

The 510(k) process has previously come under fire for being both inadequate and lacking industry support. This past June, the Government Accountability Office released a report criticizing the FDA for its failure to efficiently regulate the medical device industry. As detailed by ExpertINSIGHTS, the report was highly critical of the FDA’s lack of a comprehensive recall management strategy for faulty and unsafe medical devices. The report recommended that that FDA create a program to routinely and systematically assess medical device recall information in order to proactively identify strategies for mitigating the health risks associated with recalled products.

An industry wide survey conducted by Northwestern University earlier this year found a serious lack of confidence in the 510(k) review process. Among the survey’s findings, two-thirds of industry representatives said they planned on seeking European clearance for their products before entering U.S. markets. Only eight percent of those surveyed cited the 510(k) process as the most predictable regulatory system available.

This latest criticism of the 510(k) process is likely to carry greater weight with the FDA since it seeks out new ways to revamp and update its approval process and recall management strategies. Speaking with the Times, the FDA’s chief scientist, Dr. William Maisel,  said that although the FDA is not required to accept the report’s recommendations, “it would be difficult to find a more reputable scientific organization than the Institute of Medicine.”

As both the medical device industry and the FDA react to the Institute of Medicine report, medical device manufacturers, retailers and patients should keep an eye out for further updates to the approval process and how they might affect the FDA’s recall management strategies.

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