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GAO Report: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process

FDA scientists complained to President-elect Obama about less-than-rigorous oversight at the agency, especially for medical devices. Now, the Government Accountability Office is saying that hundreds of devices got the FDA nod without a full-scale review.
See http://www.gao.gov/new.items/d09190.pdf