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Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff

Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 15, 2023

September 14, 2023

Center for Devices and Radiological Health

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