Before its final release, the draft guidance on assessing the benefits of the medical devices on the weight loss has been circulated with a discussion paper in the audience and demanded feedbacks by the U.S. FDA on some of the concepts concerning the guidance.
The director of the Office of Product Evaluation and Quality of the CDRH, William Maisel has also shown concerns regarding the severity of obesity and how it has grown as a major epidemic in the U.S. and has become one of the major reasons for diabetes and stroke. The FDA is particularly interested in the input on the proposed benefit categories outlined in the 14-page discussion paper and to check the parameters for weight-loss against evaluation matrices.