FDA is responsible for regulating companies that manufacture, repackage, re-label, and import medical devices sold in the United States. This is accomplished through scientific review of premarket data submitted by a medical device manufacturer to establish a device’s safety and efficacy and then once on the market, monitoring medical device adverse event reports to detect and correct device-related problems in a timely manner.
It is important to note because the FDA’s scope of work is to regulate the medical device industry, the FDA cannot and does not recommend specific medical devices for use in any setting. Review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population.
