A final guidance, “Design Considerations for Devices Intended for Home Use,” issued by the FDA, 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 are associated with unique risks created by the interactions among the user, the 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.