Previously FDA-approved weight-loss devices are all indicated for “weight loss.” However, under the concept being proposed in FDA's discussion paper, future medical devices intended for weight loss may have indications that are more specific to the measured benefit, such as “short-term limited weight loss." These more specific indications would provide additional information about the intended use of the device and promote further transparency and consistency in expectations of performance, FDA said.
The proposed concept in the paper is not intended to reflect a new level of performance necessary to support marketing approval for weight-loss technologies. FDA said it intends to consider all comments submitted to the docket within 90 days. Then, the agency will develop and publish draft guidance that will be open for additional public comment.