Benefit-risk assessment

FDA uses this weighing in its decisions on clinical studies and marketing. The benefit and risk sides both need evidence; a device with modest benefit can still be acceptable if its risks are low, and the reverse.

The probable benefit to health from the use of a device weighed against any probable injury or illness from such use.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary