Despite criticism, FDA process deemed safe

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Despite criticism, FDA process deemed safe

by Heather Mayer, DOTmed News Reporter | September 16, 2010
A study released Wednesday by the Advanced Medical Technology Association (AdvaMed) confirms the safety of the U.S. Food and Drug Administration's 510(k) clearance process, the premarket review process for low- and moderate-risk devices.

The research, conducted by the Battelle Memorial Institute, and funded in part by AdvaMed, found that of the 47,000 medical devices cleared by the FDA through the 510(k) process since 1998, only 0.16 percent were involved in a Class I, or serious, recall. Class I recalls involve products that have the potential to cause serious health problems.

"The 510(k) process has an extraordinary safety record," David Nexon, senior executive vice president of AdvaMed, told reporters in a call Wednesday. "It's hard to imagine that any other regulatory process has as good a record at weeding out products before reaching patients."

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Battelle analyzed publicly available information from both the FDA and companies with affected products. It based its findings on the 77 Class I recalls reported by the FDA from January 2005 through May 2010.

Of the devices cleared since 1998, only 0.08 percent were recalled for design reasons that should have been detected during the 510(k) process, according to the report.

"This study highlights the remarkable safety record of FDA's 510(k) process," said James Mazzo, chairman for AdvaMed, in prepared remarks. "This process has served American patients well for more than 30 years by providing timely access to new and improved treatments and diagnostics while fostering medical progress."

The study, the third of its kind in the past two months, comes after the FDA proposed some 70 changes to the process this summer. The proposed reforms, industry experts argue, will threaten the U.S. medical device market, by hindering clearance and impeding innovation.

"This study was done at a time when the FDA drafted proposed reforms to the process - the most sweeping proposed reforms in the history of the program," said Nexon.

But not all of the FDA's proposed reforms are being challenged by the medical device industry. AdvaMed said the FDA's recommendations regarding increased reviewer training, development of additional guidance and greater communication of reviewer decision rationale could address deficiencies that result in delays and inconsistencies in the program, noted by the FDA.

The Battelle research complements two recent studies that reaffirmed the safety of the 510(k), one from Ralph Hall of the University of Minnesota and one from Dr. William Maisel of Beth Israel Deaconess Medical Center. Hall's study found that the rate of Class I recalls for 510(k)-cleared products was less than 0.2 percent. Maisel's study looked at all classes of recalls and found a recall rate in the range of 1.0 to 1.5 percent.