Some risk will be associated with all medical products and devices. 2 Reasonable risk means that there is a balance between the benefit gained from the product and the amount of alternatives available instead of that product. Much of this balance is maintained through proper development, testing, manufacturing, labeling, prescribing, and use of the medical product. This task force examined both premarket and postmarket risk assessment and surveillance, and evaluated the roles of the participants that evaluate risk. The FDA evaluates risks and benefits in terms of the population.
Healthcare providers evaluate risks and benefits in terms of their patients.
The patient evaluates risks and benefits in terms of their personal values. When using a medical product results in a patient's serious injury or death, the patient is said to experience a serious adverse event. A significant portion of FD A s resources are currently devoted to regulating product quality. Although additional resources are needed to maintain and enhance current oversight activities, the risks associated with defective medical products are relatively well managed. When using a drug or other medical product, a patient runs the risk of experiencing reactions resulting from the produc t s interaction with the body.