ABSTRACT
This chapter focuses on medical devices distinct from the larger universe of drugs, biologics, and foods that constitute the portfolio of regulatory responsibilities of the US Food and Drug Administration (FDA), since it is not practical to address all products in the space provided. The FDA's regulatory science priorities are focused on issues relevant to oversight of products subject to its regulations. The chapter focuses on applications of nanomaterials, evaluating the products that contain nanomaterials, classification of medical devices for regulatory purposes, and the FDA's approach to regulation of nanotechnology products. Materials can exhibit new or altered physicochemical properties at nanoscale dimensions, which can enable the development of novel products. The changes in biological, chemical, and other properties that make nanotechnology applications so exciting also leads to examine whether these changes in properties may have any effects on product safety, effectiveness, or other attributes.
