Medical devices: the obvious, the readily-accepted, and the surprising

The Food and Drug Administration's (FDA or the Agency) interpretation of the definition of a medical device in the Federal Food, Drug, and Cosmetic Act is very broad. Thus, the Agency has authority to regulate most products that have a health purpose or affect a person's body as medical devices unless they are clearly drugs or biologics. The primary purposes of this article are to help executives, managers, attorneys, regulatory professionals, healthcare providers, and consumers: (1) identify products that are potentially medical devices; (2) determine whether FDA is likely to regulate them as medical devices; and (3) if so, determine the applicable premarket requirements, if any. This article discusses the statutory criteria of a product's intended use, technological characteristics, and mode of action, and shows how FDA applies these criteria to determine whether a product is a medical device. This article provides examples of the Agency's interpretation of the statutory definition of a medical device and shows how to analyze whether a product is an FDA-regulated medical device.