Study: FDA Should Up Oversight of Med-Tech Devices

A new medical study says that a less rigorous approval process has allowed potentially harmful products to enter the market-but it sparked criticism that its findings contain "factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology with no corresponding safety benefit."

At a time when lawmakers and medical device manufacturers are engaged in dialogue regarding proposed changes to the process by which most medical devices enter the market-and the widespread implications for Minnesota's economy-a new study suggests that the current review system needs to undergo serious changes to ensure safety.

A medical study published on Monday contends that many of the medical devices that have been recalled by the U.S. Food and Drug Administration (FDA) due to safety risks reached the market through the 510(k) approval process.

The study, which was released by the Journal of the American Medical Association (JAMA), examined the FDA's list of device recalls from 2005 to 2009. It looked at whether the recalled devices were approved by a more rigorous pre-market approval process, the less stringent 510(k) process, or if they were exempt from FDA review altogether.

The 510(k) approval process is a 35-year-old system that is meant to provide a more time- and cost-efficient route to introduce devices to the market, and most medical devices are cleared this way. The process requires the device to be substantially similar to another one that's already on the market, rather than requiring clinical trials or manufacturing inspections to demonstrate safety. It's designed to allow manufacturers to make improvements to existing devices without going through another extensive approval process.

The study found that the more intensive approval process was used for only 19 percent of the recalled high-risk devices, while 71 percent were cleared through the 510(k) process.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy,” the study states.

The study recommends that the FDA increase oversight of the 510(k) approval process, including measures like post-market surveillance, inspection of the manufacturing process, and revised definitions of what characterizes a “high-risk” device.

The study immediately sparked debate, including a rebuttal from the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed), which said that the report “contains factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology with no corresponding safety benefit.”

“Simply put, this paper is seriously flawed and inconsistent with three previous analyses of the same data set conducted by respected researchers,” AdvaMed President and CEO Stephen J. Ubl said in a statement.

Among its arguments, AdvaMed contends that, while the 510(k) process doesn't require clinical trials or manufacturing inspection to demonstrate safety, “the process is a rigorous one and FDA has the authority to require any data it thinks necessary to clear the device.”

AdvaMed says that the FDA requires some form of clinical data for many of the devices, even if it doesn't entail a “full-blown clinical trial.” Also, the FDA can require pre-clearance inspections when it determines that they are appropriate and can inspect any manufacturing plant at any time.

The new study is part of a larger discussion regarding the controversial FDA approval process. Late last year, Minnesota legislators on both sides of the political aisle voiced concern about changes that were initially proposed. They sent a letter to FDA Commissioner Margaret Hamburg, encouraging the agency to consider the impact that a new set of recommendations would have on patient access to devices and Minnesota's economy.

“As you know, Minnesota has an active and continually growing medical-device industry,” the letter said, pointing out that Minnesota is home to more than 500 medical-device companies that together employ almost 35,000 Minnesotans whose jobs pay nearly 50 percent more than average statewide earnings.

The FDA recently unveiled new guidelines meant to update the 510(k) approval process. The changes include 25 actions that the FDA intends to implement this year, although it is still mulling certain decisions that could have significant impacts on the industry.

Ubl said in a statement that the safety record of the 510(k) process is “excellent,” although “there is always room for improvement.” He said that the FDA's recently announced reform plans are the proper method for improving a process that is “fundamentally sound.”

The lead author of the study published Monday is Dr. Diana Zuckerman of the National Research Center for Women & Families. Click here to access the study at the Archives of Internal Medicine's Web site.