Gasoline, meet fire.
A study released online Monday by the Journal of the American Medical Association (JAMA) claims that most medical devices recently recalled by the Food and Drug Administration (FDA) that posed serious risks to patients were approved through the controversial 510(k) clearance process or were exempt from regulatory review entirely.
Translation: Shoddy oversight by the FDA has permitted potentially unsafe products on the market.
The 510(k) method of device approval requires manufacturers to prove that a new device is “substantially equivalent” to one currently on the market — usually without clinical data to prove the product is safe and effective. In recent years, it has drawn harsh criticism from consumer watchdog groups and some members of Congress. Dr. Jeffrey Shuren, the FDA’s new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine (IOM) will weigh in with the findings of its own review this summer.
“Our findings reveal critical flaws in the current FDA device review system, and its implementation will require either Congressional action or major changes in regulatory policy,” wrote the JAMA study’s lead author, Dr. Diana Zuckerman, of the National Research Center for Women & Families. The study will be published in the June 14 print edition of the Archives of Internal Medicine.
Zuckerman and her co-authors looked at medical device recalls between 2005 and 2009 and found 113 were the most-serious classification, meaning they could cause injury or death. Of those, 21 of the devices were approved through the most-rigorous kind of approval pathway, while 80 were cleared through the 510(k) pathway. Eight were exempt from regulation, and the remaining four were counterfeit products or categorized as “other.”
An editorial that accompanies the JAMA study, written by Dr. Rita Redberg of the University of California-San Francisco’s medical school, opines that “the public deserves better protection.” Redberg calls for the 510(k) process to be strengthened “to protect Americans from avoidable injuries and death.”
As word leaked out about the study, the med-tech industry organization AdvaMed went on the offensive, saying the JAMA study is “seriously flawed and inconsistent” with previous research on the same topic. Stephen Ubl, the Minnesota native who heads AdvaMed, noted the paper “is marked by a large number of factual errors and misleading inferences.” The 510(k) process has an excellent safety record, he said.
On Monday, Zuckerman responded to AdvaMed’s criticism of her study. Noting that AdvaMed is an industry organization, Zuckerman writes, “They are therefore more concerned with getting products to market quickly than they are with ensuring that those products are as safe and as effective as possible, or even as safe and as effective as other products already on the market.”

Janet Moore covers medical technology for the Star Tribune.