The vast majority of medical devices recalled by the US Food and Drug Administration (FDA) because of increased risk of serious harm or death were approved for marketing without clinical testing, and the agency did not require postmarketing studies to determine safety and efficacy, say the authors of a study appearing today in the Archives of Internal Medicine.
The authors analyzed the FDA’s list of recalled high-risk devices from 2005 through 2009 and identified 113 such recalls. Only 21 of those 113 devices were approved through the agency’s most stringent approval process. The rest entered the market because they were completely exempt from FDA regulation or were approved through a process in which a company had to demonstrate only that the device was substantially equivalent to another device already on the market.
Here, Diana M. Zuckerman, PhD, the study’s lead author and president of the National Research Center for Women & Families in Washington, DC, explains why she, and her colleagues, conducted the research.
“My perspective is as a public health person, and I am spending a lot of time thinking about how to improve the quality of medical care. One of the big problems is the low standards that medical devices are held to for entering the market as compared with prescription drugs. The vast majority—thousands of medical devices—are not subject to clinical trial requirements at all. A company only has to say its product is similar to another product already on the market; it shows some bioengineering data, but there is no testing on humans.”
“We found that some of these devices were approved by the FDA using these lower standards even though the FDA admits they were high-risk medical devices. The FDA is supposed to hold certain devices to this higher standard and they are not doing it. They are classifying some products as moderate risk, even though some might kill you.”