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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF Only)
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF Only)

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