The procedures by which the Food and Drug Administration approves drugs and medical devices for use in the United States were addressed in a cluster of reports from the Congressional Research Service.

How FDA Approves Drugs and Regulates Their Safety and Effectiveness, June 25, 2012

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, June 25, 2012

FDA Regulation of Medical Devices, June 25, 2012

The FDA Medical Device User Fee Program, June 25, 2012