Small Business Guide to FDA
(last revised on 03/31/04)

INTRODUCTION

The Food and Drug Administration (FDA) recognizes that dealing with a large organization can frequently be a time consuming, frustrating experience. Although there is no acceptable panacea, FDA has instituted a number of activities aimed at easing this problem for regulated small businesses. These include the establishment of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in the Center for Devices and Radiological Health, Small Business Assistance Programs in the five FDA regional offices, and the creation of small business assistance offices in each of the Centers. These units provide technical assistance to small companies, hold exchange meetings to hear the views and perspectives of small businesses, conduct educational workshops, develop informational materials, and provide an accessible, efficient channel through which small businesses can acquire information from the FDA. The primary purpose of these activities is to increase our communication with the small business community. This, in turn, opens the door for improved understanding and a better working relationship. Because FDA regulates a wide range of products - from aspirin to x-ray equipment - we could not tailor this booklet to exactly fit everyone's operation. Instead, we have compiled some basic yet important information about FDA that, when put to use, will facilitate your interactions with the Agency. If you want to know about FDA's organization, procedures, policies, and regulations, we suggest that you keep this booklet handy. It contains a lot of good information for firms like yours.