On this page:
- September 2023 Draft Guidances Issued
- September 2019 Discussion Paper
- June 2018 Patient Experiences with Weight-Loss Devices Listening Session
- Patient Risk Tolerance Survey
- Benefit-Risk Assessment Model for Clinical Trial Design of Obesity Treatment Devices
- June 2014 Panel Meeting
- May 2012 Panel Meeting
- October 2011 Co-Sponsored Workshop
On September 15, 2023, the FDA issued the following draft guidances for medical devices with indications for use associated with weight loss:
- Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations
- Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations
On September 5, 2019, the FDA published a discussion paper, Consideration of Benefit-Risk Approaches for Weight-Loss Devices. The discussion paper describes a concept that the FDA was considering to assess the safety and effectiveness of weight-loss devices and describes and highlights areas where the FDA sought input from stakeholders.
The FDA's Center for Devices and Radiological Health (CDRH) held a listening session on June 28, 2018, with patients who used FDA-approved weight-loss devices. Patients provided feedback to regulators about their expectations for these devices and treatment decision-making process, the impact on their quality of life, their level of satisfaction with their results, and input on patient resources needed to achieve their weight-loss goals.
The FDA's Center for Devices and Radiological Health (CDRH) has worked with the Research Triangle Institute Health Solutions (RTI‐HS) to carry out the first national benefit‐risk preference study to provide information on patient risk tolerance. The study surveyed 654 obese patients to assess how much risk they would tolerate to lose weight. To assess benefit-risk preferences before and after having a procedure, the survey included 23 patients who had previously undergone gastric bypass or banding procedures. In addition, the preferences of those patients who underwent gastric bypass or banding procedures were compared with those who did not. The results of this survey provide significant information on patient benefit-risk preferences, and helped the FDA understand the applicability of a patient risk tolerance survey as a tool in FDA's decision-making process.
The Patient Risk Tolerance Survey was outlined in a journal article featured in the October 2015 issue of the Journal of Surgical Endoscopy.
The FDA proposed a benefit-risk assessment model to help manufacturers develop clinical studies that could provide valid scientific data on the safety of obesity treatment devices. These studies would help the FDA to make well-informed regulatory decisions. The benefit-risk assessment model included 11 categories of expected and unexpected events that could occur following device placement, collected from available clinical data and real-world use of the devices. Based on the percentages of patients experiencing events in each category in the year following device placement, a new medical device could be assigned to one of four risk levels. The FDA also proposed different effectiveness targets for the different risk levels.
The proposed model included many of the important concepts of benefit-risk assessment, such as:
- Type of benefit
- Level and duration of benefit
- Probability of a patient experiencing benefit
- Number, severity, and types of harmful events associated with the use of the device
- Probability of a harmful event
The FDA's proposal was outlined in a journal article featured in the March 2013 print issue of the Journal of Surgical Endoscopy.
On June 17, 2014, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee discussed, made recommendations and voted on information regarding the premarket application (PMA) for the Maestro Rechargeable System sponsored by Enteromedics, Inc.
On May 10-11, 2012, the Gastroenterology and 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. The FDA presented background information to the Panel on the following topics:
- FDA-approved weight-loss treatment devices
- Published literature regarding benefits of weight loss
- Options for control arms in clinical studies
In addition, the FDA discussed current efforts to explore ways to incorporate patient preferences in the decision-making process that leads to approval of new medical devices. The FDA also presented a benefit-risk assessment method for categorizing and quantifying risk for the purposes of identifying an acceptable effectiveness target.
For more information about this panel meeting click the following link: May 10-11, 2012: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.
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)."
The DDOMD workshop consisted of lectures and panel discussions addressing the following key topics:
- Overview - The Epidemic of Obesity and Metabolic Disease
- Optimization of Clinical Trial Design: Controls and Blinding
- Case Presentations - Previous Device Trials
- Inclusion Criteria and Outcome Targets
- Device Development Strategies and Regulatory Considerations
- Clinical Perspective
- Industry Perspective
- Payer Perspective
- Looking to the Future