In Focus: Risk Management of Medical Products
Posted 01 July 2010 | By
In this issue of Regulatory Focus we explore current practices for managing the risks of medical products. The US Food and Drug Administration (FDA) and its counterparts around the world are responsible for protecting public health by ensuring the safety and effectiveness of drugs and devices. To achieve this mission, regulators must decide whether a given product's benefits to patients and users outweigh its risks, while recognizing that "absolute safety" is not achievable.