Medical device recalls in the US and Europe occur at the same rate, even though the approval process in the US takes significantly longer, according to a new report released by the Advanced Medical Technology Association (AdvaMed).
The study analysed the number of medical devices recalled due to health risks in Europe and US from 2005 to 2009.
The study found that the average number of device recalls in Europe was 21 per year, which was almost equivalent to the average number of recalls in US.
AdvaMed president and CEO Stephen Ubl said it is well-documented that it takes longer to bring medical technology to market in the US than it does in Europe.
"The report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety," Ubl added.
According to a new study by Stanford professor Josh Makower, on an average, FDA reviews for 510(k) products take two years longer when compared reviews for similar products in Europe.