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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.
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