Regulatory pathways to the market: an overview.

This paper presents an overview of the U.S. Food and Drug Administration's regulatory requirements for introducing medical device and diagnostic products into commercial distribution in the United States. For any specific product, the requirements vary depending upon the product's associated risks, classification, and when it or a similar product was first introduced into commercial distribution. Regulatory pathways available and/or required for a manufacturer to introduce a medical product into the U.S. marketplace are outlined.