| dc.description.abstract | The Office of Combination Products (OCP), within the Food and Drug Administration (FDA), was created formally by statute in December, 2002. Upon its creation, the Office became broadly responsible for overseeing the regulation of combination products, or products that involve components that would normally be regulated under different FDA Centers. But the statutory creation of this Office in one day represented the culmination of nearly sixty-five years of both technological advancement in the products submitted to the FDA and amassed experience within the FDA and its administrative predecessors for managing those products in the name of the public safety. To understand the need for this Office and its primary goals of timely, effective and clear regulation of these groundbreaking technologies, the history of the FDA with respect to the advent of these combination products must be examined chronologically. Drafts of statutes, administrative proposals offered for public comment, and lengthy debates from Capitol Hill all illustrate the journey that led inevitably to the OCP as a final destination. Nearly twenty-four months have passed since the OCP was created, so an analysis of its initial progress through an explanation of the changes it has effected is necessary. Both combination product manufacturers and FDA jurisdiction officers have benefited from industry guidances, enhanced inter-Center communication, and a wealth of expertise provided by FDA employees eager to streamline the regulatory pathways to be navigated. Thus, the next three years within the OCP would seem to promise similar success for product manufacturers, the FDA and the American public. | en |
