OBJECTIVES: In collaboration with FDA’s Center for Devices and Radiological Health (CDRH), we developed and administered a best-practice discrete-choice experiment (DCE) survey to elicit preferences for outcomes associated with using weight-loss devices to demonstrate how DCE data can help determine meaningful benefits for regulatory decisions involving serious side-effect risks. METHODS: An online DCE questionnaire was administered to adult residents of the United States who reported having or having had a body mass index (BMI) of at least 30 kg/m2.  Respondents evaluated constructed hypothetical weight-loss devices with different features identified with the help of clinicians at CDRH. Weight-loss devices were defined in terms of device effectiveness, device-related risks of side effects, surgery requirements for implantation, and diet restrictions. An efficient experimental design ensured that device profiles provided the necessary statistical information to identify the choice-model parameters.  Random-parameter choice models produced preference weights indicating the strength of preference for device features. These weights were used to calculate the maximum acceptable risk of dying or minimum required weight loss associated with various device profiles. RESULTS: 540 respondents completed the online survey. Results from the study show that respondents had well-defined, plausible preferences for different outcomes associated with weight-loss devices.  Internal validity tests, including a scope test of sensitivity to absolute risk levels, indicated the data are of high quality.  Preference results were used to construct an Excel-based tool that calculates the necessary benefits to offset the device-related risks with confidence intervals for any device that can be described by features included in the study design. CONCLUSIONS: Results confirm the feasibility of using DCE methods to evaluate patients’ tolerance for weight-loss device risks, as well as the feasibility of constructing a policy-relevant decision aid that makes this information accessible to regulators.