The oversight of medical products was added to the High Risk List in 2009 because the Food and Drug Adminstration (FDA) was facing a variety of difficulties that threatened to compromise its ability to protect the public health. The 2009 report is updated here. While progress has been made, challenges remain.
http://www.gao.gov/highrisk/protecting_public_health/why_did_study?utm_source=blog&utm_medium=social&utm_campaign=watchblog#t=0