Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis

The Food and Drug Administration’s (FDA) regulation of biomaterial product commercialization has evolved considerably since the passage of the Food, Drug and Cosmetic Act of 1938. The regulation of biomaterials does not differ substantially from the regulation of other medical device and biologic products from a framework perspective, but does from an application perspective. Therefore, having an understanding of the key regulatory processes involved in device commercialization is vital to developing an understanding of the those processes for biomaterials. In this chapter, we will explore key pieces of US legislation that impact biomaterials product regulation, and begin to review parameters around which commercialization strategies for biomaterials products can be developed.