Entering the U.S. medical device market

Bringing a medical device to the United States market, whether by export or by domestic manufacture, requires a strategy based on a careful consideration of the device properties. These properties include not only the physical attributes and design features, but also the intended use of the device. The U.S. Food and Drug Administration (FDA) rules provide several possible pathways for legal distribution. Finding the quickest, easiest, and least expensive pathway through the regulatory maze requires an understanding of how the device properties can limit the available alternatives. Exemptions, substantial equivalence, and investigational status offer alternatives to FDA approval for legal distribution.