Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

September 15, 2023

Last updated

September 14, 2023

Description

Draft guidance document for the FDA and industry staff on medical devices related to weight loss, including clinical study and benefit-risk considerations.

Organization

Country / Region

United States

License

Other (Public Domain)

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