Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations
Ahead of a planned draft guidance on assessing the benefits and risks of new weight-loss devices, the US Food and Drug Administration (FDA) on Thursday circulated a discussion paper to gather feedback on some of concepts the agency is considering for the guidance.“Obesity is a major public health epidemic in the US and is associated with many health problems such as heart disease, diabetes and stroke. Having a variety of weight-loss treatment options available, including devices, increases the number of patients who could benefit from therapy,” said William Maisel, director of the Office of Product Evaluation and Quality within the Center for Devices and Radiological Health.
Specifically, FDA says it is looking for input on the proposed benefit categories outlined in the 14-page discussion paper, as well as feedback on adverse event classification and whether evaluation matrices may be useful to compare benefits and risks for weight-loss devices.
“The concepts discussed in this paper focus on how to consider the extent of weight loss in relation to the extent of adverse events for weight-loss devices. This assessment would be considered along with other factors as part of FDA’s benefit-risk assessment of a new weight-loss device submitted to the agency for premarket review,” FDA writes.
FDA says it will consider the feedback it receives on the discussion paper over the next 90 days when developing an upcoming draft guidance on assessing the safety and effectiveness of weight-loss devices.
In the discussion paper, FDA presents four benefit categories it is considering for weight-loss indications for medical devices: short-term limited weight loss, limited weight loss, short-term weight loss and weight loss.
Each benefit category would have a defined superiority margin for total body weight loss (TBWL) compared to a control and a response threshold of 50% of patients responding to the device with greater than five percent TBWL. FDA says these parameters “are consistent with the benefit demonstrated for FDA approved devices for weight loss that are currently on the market.”
FDA also says that devices with short-term indications should be used for a duration of six to 12 months, whereas devices meant for longer-term use should be used for at least 12 months.
For the consultation FDA asks whether the benefit categorizations and durations are appropriate and if the proposed superiority margins are clinically meaningful.
As for risk, FDA proposes a five-tier grading classification for adverse events adapted from the Clavien-Dindo Classification for surgical complications, ranging from Grade I, which includes “any deviation from the normal treatment course without the need for surgical, endoscopic, and radiological interventions,” to Grade V, which would be an adverse event resulting in a death.
FDA says it is looking for feedback as to whether the adverse event classification scheme is appropriate for the types of adverse events anticipated for weight-loss devices and whether there are types of adverse events not captured by the proposed scheme.
The discussion paper also presents evaluation matrices for each of the four benefit categories that grades the device against the rate and severity of the adverse events observed during clinical studies.
Discussion Paper, Public Docket