The Advanced Medical Technology Association (AdvaMed) has issued a report showing that while the FDA medical device approval process in the United States takes significantly longer than in Europe, recalls in Europe and the United States occur at about the same rate.
"[The] report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety," said Stephen J. Ubl, AdvaMed President and CEO, in a news release from AdvaMed.
When AdvaMed examined the rate of medical device safety recalls for the United States and Europe from 2005-2009, it was almost identical.
Read the AdvaMed news release about the study of medical device approval safety.
Read the report by clicking here (pdf).
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