Medical device review process to be investigated by IOM

The Food and Drug Administration (FDA) has asked the Institute of Medicine (IOM) to review the current process for approving medical devices, reports the Wall Street Journal. The request comes after the FDA recently came under fire for rapidly approving certain devices. The current process allows device makers to market products without having those products undergo in depth trial testing. Devices can be cleared for marketing as long as they are similar to other devices already in existence. However, the current process is viewed by many as too quick, allowing devices that should not be cleared for use available for use.

The IOM expects its review, which will cost $1.3 million, will run through 2011. The medical device industry defended its practices. It has expected changes, however, since the Obama administration announced changes in leadership at the FDA earlier this year.

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