The controversial approval process the Food and Drug Administration uses for most medical devices has in fact enjoyed an "extraordinary safety record" in the past five years, according to a report commissioned by a medical technology industry group.
The report issued Wednesday by Washington, D.C.-based AdvaMed comes at a time when the regulatory pathway for most medical devices is being studied by new leadership at the FDA, as well as the Institute of Medicine, an independent entity that provides advice to policymakers.
At issue is the FDA's 510k approval process, which is the way approximately 73 percent of medical devices get clearance before being marketed in the United States, often without clinical studies to prove the product is safe and effective in patients. Medical device makers must simply prove a product is "substantially equivalent" to one already on the market.
Critics contend the 510(k) process has permitted potentially unsafe products to infiltrate the marketplace.
The consumer group Public Citizen, for example, says more rigorous scientific evidence is needed to prove many 510(k) devices are safe. And the American Association for Justice, a group of plaintiff's lawyers, argues that these devices should be followed more closely once used in patients and that the FDA should have the power to repeal approval if new safety data surfaces showing a product is unsafe.
But the AdvaMed report, conducted by the independent research firm Battelle Memorial Institute, disputes those claims.
"This study provides a terribly useful framework for evaluating these sweeping reforms," said David Nexon, AdvaMed's senior executive vice president. "It's hard to imagine any other regulatory process with as good a record as this."
The 14-page report analyzed recall data culled from public documents and from company safety alerts. Of the 46,690 medical devices cleared through the 510(k) process since 1998, just 77, or 0.16 percent, were part of a Class 1 recall between 2005 and 2010.