To add to other posts on this forum, another factor to consider during benefit-risk analysis is patient perspectives. If the risks are identifiable and definable, risk tolerance will vary among patients, and this will affect individual patient decisions as to whether the risks are acceptable in exchange for a probable benefit. As mentioned in the guidance within the first question on this forum, FDA recognizes that patient perspectives on benefits and risks may reveal reasonable patients who are willing to tolerate a very high level of risk to achieve a probable benefit, especially if that benefit results in an improvement in quality of life. Therefore, manufacturers should take into account patient’s willingness and unwillingness to use a device or tolerate risk in exchange for probable benefit, and/or evaluate how patients view trade-offs between benefits and risks of various treatment options (if available).