The FDA has recognized that medical devices are moving from the professional realm into the home use arena. Their new final guidance was released to address home use of medical devices through adequate design. The elements of design discussed include environmental considerations, temperature, storage, travel, international use, user considerations, human factors as well as labeling. Minimization of risk is the overarching theme of the entire document, and the FDA requests that home usage of devices be taken into consideration when submitting a premarket submission. This is a good guidance document for all medical device manufacturers, even if the device is not used in the home market. It can be used while doing risk determination to make sure that all areas are covered in the design documentation and subsequent risk documentation.
If you have any questions about how to use this guidance document and if it applies to your product, give Regulatory Specialists a call.
The full guidance can be downloaded as a pdf here :