The Food and Drug Administration (FDA) is facing a flurry of new products coming to market over the next few years that will be based on biotechnology. The agency will have to deal with state-of-the-art drugs and devices utilizing biotechnology as the developmental base. Also, many universities and companies are exploring the potential uses of biotechnology in developing new foods and food additives. This article will examine how the FDA is presently regulating medical device, and food and food additive biotechnology and the challenges confronting the agency in these areas in the future.