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Guidance Documents/Guidance-Document/Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff

Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

March 13, 2026

March 12, 2026

Center for Devices and Radiological Health

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