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  1. Weight-Loss and Weight-Management Devices

FDA Activities: Weight-Loss and Weight-Management Devices

March 2026 Final Guidance Issues

On March 12, 2026, the FDA issued the final guidance for medical devices with indications for use associated with weight loss, “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” This guidance document provides recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions, and also includes discussion on how the FDA considers the benefit-risk analysis to support such indications. The FDA has previously engaged stakeholders regarding how we can help to ensure patients have access to safe and effective devices indicated for weight loss and incorporated the feedback as appropriate in this guidance.

Prior Agency Actions 

  • In September 2019, the FDA requested public comment regarding the benefits and risks associated with devices indicated for weight loss in the discussion paper: Consideration of Benefit-Risk Approaches for Weight-Loss Devices. 
  • On June 28, 2018, the FDA held a listening session with patients who have used FDA-approved devices with indications associated with weight loss. 
  • In 2015, the FDA worked with the Research Triangle Institute Health Solutions (RTI‐HS) to conduct the first national benefit‐risk patient preference study to provide information on patient risk tolerance for weight loss devices. The study was published in the October 2015 issue of Surgical Endoscopy.
  • In 2013, the FDA published a benefit-risk assessment paradigm in the March 2013 issue of the Journal of Surgical Endoscopy that could provide an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity. 
  • On May 10-11, 2012, the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee discussed general issues related to obesity treatment devices and provided clinical study design recommendations to better evaluate the safety and effectiveness of obesity treatment devices.
  • On October 16-18, 2011, the FDA, Dartmouth Device Development/GI at Dartmouth Medical School, and the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital co-sponsored a two-day workshop, "Device Development in Obesity and Metabolic Disease (DDOMD)."
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