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Today, the U.S. Food and Drug Administration (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
The draft guidances for medical devices with indications for use associated with weight loss, when finalized, will provide:
- Recommendations for non-clinical testing to support premarket submissions for these devices.
- Recommendations about clinical study design for these devices.
- Discussion on how the FDA considers the benefit-risk analysis to support such indications.
Note: These guidances are not for implementation at this time.
Submit comments
Submit comments under docket number FDA-2019-N-4060 at www.regulations.gov by November 14, 2023 to ensure the FDA considers comments on the draft guidances before it begins work on the final versions of the guidances.
Questions?
If you have questions about these draft guidances, contact the Division of Industry and Consumer Education.
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