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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!

  1. 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
    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

    Center for Food Safety and Applied Nutrition (CFSAN)
    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
    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

  2. FDA Office of Regulatory Affairs (ORA)

    ORA Small Business Representative
    David Arvelo
    FDA - Dallas District Office
    1201 Main Street, Suite 7200
    Dallas, Texas 75202
    Phone: 214-253-4979

    FDA Public Affairs Specialists and ORA District Offices
    Contacts for ORA and District Offices can be found in the following resources:

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

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