Small Business Assistance

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 Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health, CDER Small Business and Industry Assistance (SBIA), 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.

Are you a small business with questions about your FDA-regulated product?
Or, do you wonder if your product needs to be approved by the FDA?
Contact us!

U.S. Food and Drug Administration (FDA) Headquarters

Center for Biologics Evaluation and Research (CBER)
Office of Communication, Outreach and Development (OCOD)
Division of Manufacturers Assistance and Training (DMAT)
Manufacturers Assistance and Technical Training Branch(MATT)
Food and Drug Administration
10903 New Hampshire Avenue
Building 71, Room 3103
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-7800
Email: Industry.Biologics@fda.gov

Center for Drug Evaluation and Research (CDER)
Office of Communications
Division of Drug Information (DDI)
Brenda Stodart, PharmD
CDER Small Business and Industry Assistance (CDER SBIA)
10903 New Hampshire Avenue
WO-51- 2201
Silver Spring, MD 20990-0002
Phone:
Toll-free and International: 866-405-5367
Local: 301-796-6707
Fax: 301-847-8715
Email: CDERSBIA@fda.hhs.gov

Center for Devices and Radiological Health (CDRH)
Office of Communication and Education (OCE)
Division of Industry and Consumer Education (DICE)
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-7100 or 800-638-2041
Email: DICE@fda.hhs.gov
DICE Homepage

Human Foods Program (HFP)
Division of Education, Outreach & Information
Information Center Branch
Food and Cosmetic Information Center, HFS-009
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
1-888-SAFEFOOD
1-888-723-3366
10 AM - 4 PM ET
Closed Thursdays 12:30 PM – 1:30 PM ET
Inquiries: Submit Your Question

Center for Tobacco Products (CTP)
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 1-877-CTP-1373 (1-877-287-1373)
Monday–Friday, 7:30 a.m.–6:00 p.m. EDT
E-mail: SmallBiz.Tobacco@fda.hhs.gov
Tobacco Small Business Assistance Website

Center for Veterinary Medicine (CVM)
7500 Standish Place
Rockville, MD 20855
Phone: 240-402-7002
Email: AskCVM@fda.hhs.gov
CVM Small Business Assistance

Office of International Programs (OIP)
White Oak Building 32
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-4600
E-mail: OIPCommunications@fda.hhs.gov
International Programs Website
FDA Office of Inspections and Investigations (OII)

Contacts for OII industry assistance :
Contact the FDA Import Program | FDA
Contact ORA | FDA

Please contact the nearest OII district office listed in the OII Directory or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332). Access more information about FDA.