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  1. How to Study and Market Your Device

Other FDA Components

The Food and Drug Administration (FDA) is organized into various components which each have separate responsibilities. Each component of FDA has an office to provide technical assistance to manufacturers. This includes assistance to manufacturers of human drugs, animal drugs and devices, biological products, food products and cosmetics. These offices can be contacted for technical assistance for products regulated by the FDA other than medical devices.

Human Drug Products:

Center for Drug Evaluation and Research (CDER)
Office of Communications
Division of Drug Information
10001 New Hampshire Avenue
Hillandale Building (4th Floor)
Silver Spring, MD 20993 USA
Telephone Number: 301-796-3400
Fax Number: 301-847-8714
CDER Home Page:https://www.fda.gov/Drugs/default.htm
Email Address: druginfo@fda.hhs.gov

Biological Products:

Center for Biologics Evaluation and Research (CBER)
Office of Communication, 
Outreach and Development
10903 New Hampshire Avenue
Building 71, Room 3103
Silver Spring, MD 20993 U.S.A.
Telephone Number: (800) 835-4709 or (240) 402-8010
Fax Number: 301-827-3843
Fax-On-Demand: 888-223-7329 or 301-827-3844
CBER Home Page: https://www.fda.gov/BiologicsBloodVaccines/default.htm
Email Address:
Manufacturers Assistance: industry.biologics@fda.hhs.gov
Consumer Assistance: ocod@fda.hhs.gov

Animal Drugs and Devices:

Center for Veterinary Medicine (CVM)
Communications Staff
7500 Standish Place, HFV-1
Rockville, Maryland 20855
Telephone Number: 240-402-7002
Fax Number: 301-827-4065
CVM Home Page: https://www.fda.gov/AnimalVeterinary/default.htm
Email Address:AskCVM@fda.hhs.gov

Food Products and Cosmetics:

Center for Food Safety and Applied Nutrition (CFSAN)
Outreach and Information Center
5001 Campus Drive
College Park, MD 20740
Telephone Number: 1-888-SAFEFOOD (1-888-723-3366)
Fax Number: 301-436-2618
CFSAN Home Page: http://www.fda.gov/Food/default.htm
Email Address: Submit Your Question

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