US FDA Publishes Guidance on Home-Use Medical Device Design Issues

Increasing use of medical devices used outside of healthcare facility settings has prompted the US Food and Drug Administration to issue new guidance on design considerations for manufacturers of such “home-use” products.

The guidance is meant for manufacturers to incorporate design elements into home-use devices that would minimize risks posed patients and users in home environments. Major design factors manufacturers of such devices should consider include user environment and characteristics, 21 CFR 820.30 design control requirements, as well as human factors such as user training and certification.

Labeling for home-use devices must comply with all 21 CFR Part 801 and 809.10 requirements, according to the guidance, for both over-the-counter and prescription-only products.

Manufacturers whose devices fall into the home-use category—which includes many mobile medical apps and technologies—should pay close attention to the FDA’s new guidance in order to anticipate how the agency will approach premarket reviews, post-market surveillance and quality system inspections for home-use device registrants.

Stewart Eisenhart

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