Study finds majority of recalls come from 510(k) processed devices

Although quicker FDA reviews help bring new technology to consumers, researchers at the Cleveland Clinic--including Steven Nissen--have found that the speed may lead to more problems. Of the 117 products recalled from 2005 to 2009, 80 underwent a 510(k) review rather than a lengthier process. One area hit particularly hard were heart devices, which made up 31 percent of the total device recalls.

"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," write Nissen and Diana Zuckerman of the National Research Center for Women & Families.

FDA spokeswoman Karen Riley is not surprised that more recalls came from the 510(k) process; however, she emphasizes the majority of products that undergo the expedited review don't have problems.

"Even one recall is too many," Riley said in an email to the Washington Post. "But, considering that more than 19,000 devices were cleared via the...process between 2005 and 2009, it's important to keep the 80 recalls in perspective. They represent a small number of the devices cleared via this program and don't reflect the thousands of people who have benefited from these devices."

The Cleveland Clinic study was published in the Archives of Internal Medicine.

- read Reuters' take
- here's the Washington Post article

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