Most Devices in High-Level Recalls Originally Cleared in Less Rigorous Process

More than three-quarters of medical devices in the most serious level of FDA recalls were originally cleared under the less rigorous FDA approval process or were considered so low-risk that they were exempt from review, according to an Archives of Internal Medicine report.


Studying 113 recalls from 2005-2009 that could cause serious health problems or death, researchers found 71 percent were cleared through the less rigorous process and an additional 7 percent were exempted from any FDA regulation.


Researchers also found that 31 percent of the high-risk device recalls were in cardiology and 51 percent were in one of five other categories: general hospital, anesthesiology, clinical chemistry, neurology and ophthalmology.


Related Articles in Medical Device Recalls:

American Regent Initiates Recall of Vasopressin Injection Lots

Infusion Pumps Plagued by Multiple FDA Recalls

GAO Report: FDA Should Tighten Oversight of Device Recalls


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