Wednesday, April 13, 2011

GAO watchdog to fault FDA on devices - The Boston Globe

The Government Accountability Office found that the FDA has taken some recent steps to determine if certain high-risk medical devices should undergo more testing before being sold. But in the meantime, it is continuing to approve dozens of such devices with scant review.

An official with the office is expected to testify today at a hearing before the Senate Special Committee on Aging. The office will also present its preliminary findings of what it concluded were shortcomings in how the FDA oversees recalls of troubled devices.

A spokeswoman for the FDA said that officials there had not seen the GAO testimony and so could not respond. She added that FDA officials planned to testify at the hearing. The panel is also expected to hear from patient advocates and industry representatives.

Posted via email from Jack's posterous

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