Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device,” states the guidance. “This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address the entire manufacturing process—and beyond. It covers environmental issues, user issues, design issues, labeling challenges, post-market considerations, and the always-fun human factor.

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