Tuesday, January 27, 2009

FDA's Device Review Inadequacies: More

Here's this tidbit:

At least 228 medical devices between 2003 and 2007 were approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, despite assurances from FDA officials that holes in the approval process were being addressed, according to the report by the GAO.

Nearly 230 devices in essence were crammed through the process? Read the complete GAO report here in PDF.

Source here.