During March 13 testimony before a Senate committee, Food and Drug Administration Commissioner Margaret Hamburg, M.D., defended the length of time it takes the regulatory agency to review and approve medical devices. "I can assure you that the FDA review teams take their job very, very seriously, going through in a systematic way the data that's available to them, assessing safety, efficacy and overall risks and benefits to patients," Hamburg testified.
"Since fiscal year 2010, we've achieved a 27 percent decrease in the backlog of lower device applications and a 10 percent decrease in average total review time," she told the Senate Health, Education, Labor and Pensions Committee. "For higher risk devices, we've seen a 43 percent decrease in the backlog and a 32 percent decrease in average total review time."
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