Study: Recalled Devices Had Less Strict FDA Review

More than three-quarters of medical devices involved in high-risk recalls in the last five years because they could cause serious harm or death to patients did not undergo FDA premarket approval, which requires clinical testing and inspections, a study shows.

The rest is here:

Study: Recalled Devices Had Less Strict FDA Review

Posted by on February 14, 2011. Filed under Health, News. You can follow any responses to this entry through the RSS 2.0. You can leave a response or trackback to this entry