ABSTRACT
Any person who proposes to bring to market a device intended for human use is required by Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&CA) to report his or her intention to the Food and Drug Administration (FDA) at least 90 days before introducing the device into interstate commerce. Failure to comply is a violation of Section 301(p) of the FD&CA and exposes the manufacturer to both civil and criminal penalties under Section 302 of the FD&CA.
