I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other factors such as patient-centric assessments and patient-reported outcomes, characterization of the disease, alternative treatments like @dag56 has mentioned and risk mitigation strategies like @smitshah have mentioned. An important point is that the FDA also stated that “risk tolerance will vary among patients, and this will affect individual patients decisions as to whether the risks are acceptable in exchange for probable benefit” –> FDA would consider the consequences of the patient preference studies –> Patient preference specific –> Manufactures (etc.) should submit preference information (PPI) and PPI-related materials to help FDA in decision-making process.