Read the full guidance: Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB)
As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.”
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