OBJECTIVES: Through significant investment in novel technologies, upper-limb prostheses are rapidly increasing in functionality. These more advanced prostheses are expected to be submitted to the Unites States Food and Drug Administration (FDA) for regulatory review soon. Given recent guidance released by FDA, the benefit and risk tradeoffs patients are willing to make might be considered in regulatory review. We aim to demonstrate an approach for the identification of patient preference attributes for upper-limb prosthetic devices. METHODS: We engaged in evidence synthesis, expert consultation, and community engagement. To identify attributes, we conducted a targeted literature review and interviews with experts (n=10), and reviewed interviews with upper-limb amputees (n=7). We conducted a prioritization exercise through two focus groups with upper-limb amputees, end-users, and regulators and through a paper-based survey administered during a public meeting. Results from the exercise were analyzed using Best-Worst Scoring and rescaled on a 100 point scale. RESULTS: We identified 62 unique benefits, risks, and convenience attributes of upper-limb prosthetic devices. Based on expert input, we selected 16 risk items to be included in the prioritization exercise. 13 people participated in the focus groups and 34 people completed the prioritization survey. The four most influential risks were reliability (BWS score: 67.38, SE: 1.78), pain (65.78, SE: 1.62), infection (62.58, SE 1.55), and malfunction (62.41, SE: 1.70). The four least influential risks were MRI compatibility (32.09, SE: 1.68), time until use (31.38, SE: 1.80), training (30.85, SE 3.79), and outdated device (BWS: 29.96, SE: 1.78). CONCLUSIONS: This study documents rigorous development work for a stated-preference study in accordance with FDA’s patient preference information guidance. It provides an approach that can be used by FDA reviewers to evaluate preference study design. Future studies will identify upper-limb amputees’ willingness to trade between the benefit, risks, and practical aspects of prosthetic devices.