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Contacts for Additional Information about MDUFMA

If you can’t find the information you need on our Internet site, www.fda.gov/cdrh/mdufma, you can receive help with your questions by telephone or e-mail, as listed below.

Most questions -

Your best source for information about MDUFMA is the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). DSMICA staffers can answer most questions concerning medical device user fees and how to qualify as a small business, and can help you find guidance documents and other reference materials.

• DSMICA - 800-638-2041 or 240-276-3150 or e-mail to dsmica@cdrh.fda.gov

Questions concerning preparation of a Medical Device User Fee Cover Sheet -

Please review the Frequently-Asked Questions at -

https://fdasfinapp8.fda.gov/OA_HTML/mdufmaFAQ.html

If you have difficulty setting up your account with FDA, can’t use the online system, or have forgotten your user fee payment identification number, contact -

• FDA User Fees Financial Support Team - 301-827-9539 or e-mail to userfees@fda.gov

Questions concerning payment of a medical device user fee -

Please review the Frequently-Asked Questions at -

https://fdasfinapp8.fda.gov/OA_HTML/mdufmaFAQ.html

If you are unsure whether you need to file an application with FDA or are unsure what type of application to file, contact either -

• Center for Devices and Radiological Health
  DSMICA — 800-638-2041 or 240-276-3150 or e-mail to dsmica@cdrh.fda.gov 
   
• Center for Biologics Evaluation and Research
  Office of Communication, Training, and Manufacturers Assistance - 301-827-2000

If you have a questions concerning how to submit a fee payment to FDA, contact -

• FDA User Fees Financial Support Team - 301-827-9539 or e-mail to userfees@fda.gov

Questions concerning combination products -

• FDA Office of Combination Products - 301-427-1934 or e-mail to combination@fda.gov

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