FDA's Device Approvals Come Under Fire, Again

A recent study concludes that most medical devices cleared via the FDA's 510(k) and PMA processes lack sufficient evidence to show they are safe and effective. The report, published in JAMA Internal Medicine, concluded that 42 of the 50 medical devices studied did not have sufficient data backing their use.



from EETimes: http://ift.tt/1rJ1ygs

via Yuichun