Risk-benefit analysis is the comparison of the risk of a situation to its related benefits.
The FDA provided a guidance about the benefit and risk factors to be considered for making decisions concerning product availability, compliance and enforcement.

Can you tell us one of those factors and explain why it is important ?

For example:
Assessment of the Benefits of Devices includes: The type of benefits, The magnitude of the benefits, and how long the benefits can be expected to last for the patient.

Hint:
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm517504.pdf