IOM calls for FDA's 510(k) process to be scrapped
by Brendon Nafziger
, DOTmed News Associate Editor | July 29, 2011
The Institute of Medicine called for scrapping the Food and Drug Administration's 510(k) clearance process and remaking it from the ground up, as well as beefing up postmarket surveillance, in its long-awaited report released Friday.
The IOM, best known for changing hospital safety practices with its 1999 report, "To Err is Human," was tapped by the FDA in September 2009 to look into the agency's often-controversial 510(k) process.
The recommendations immediately drew the ire of device manufacturers, who said it came too late, as the FDA already released its own reform measures for the so-called "fast-track" device clearance process last summer.
"The report's conclusions do not deserve serious consideration from the Congress or the administration," Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, a device company lobby, said in a statement.
The 35-year-old process is used to bring to market moderate-risk, Class 2 devices, including most radiological equipment. The FDA received about 4,000 510(k) submissions in 2009, the IOM said.
To pass, companies have to show a new device is similar to one already on the market, called a predicate device. Generally, they don't have to submit any clinical evidence. This worries patient advocates, who believe the process has allowed potentially dangerous or untested devices to reach the market.
For their part, manufacturers say a streamlined process -- like the 510(k) -- is important for getting innovative, life-saving devices to the public, but they complain the 510(k) process has slowed considerably in recent years, and the decision-making behind it is often arbitrary and opaque.
But the IOM, in its 227-page report, comes down closer to the side of patient advocates. The 12-panel group of assorted academics, radiologists, surgeons and lawyers said the process was not able to gauge the safety of a device, nor did it promote innovation.
"The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one," the IOM said in a summary of the report.
For one, the group said predicate devices are often poor models, as they include ones from before 1976, when the FDA began regulating devices, and those devices were never properly assessed for safety or effectiveness.
The IOM also judged that the 510(k) process does not require products to be innovative, so it cannot be said to "reward innovation."
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