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U.S. Department of Health and Human Services

Medical Devices

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Presentation: Premarket Notification 510(k) Medical Device User Fees

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Marjorie.Shulman@fda.hhs.gov

Marjorie Shulman
Office of Device Evaluation
Program Operations Staff
Premarket Notification Staff

MDUFMA

Medical Device User Fee Modernization Act of 2002

User Fees for Device Reviews
www.fda.gov/oc/mdufma
MDUFMA

Types of Premarket Applications Submitted to CDRH Requiring a User Fee:
 

  • 510(k)s
  • 513(g)s
  • PMAs
Step #1 in User Fee Process
  • Obtain Small Business Determination (SBD)
    www.fda.gov/oc/mdufma
  • Guidance allows 60 days to process SBD, but is currently reviewed in 10-15 days.
  • Must receive “SBD number” before going to next step

Please Note:
Businesses not qualifying as “small” can skip this step and continue on to the user fee cover sheet.
 

Step #2 in User Fee Process
Step #3 in User Fee Process
  • Payment & 510(k) are mailed to separate addresses
  • Generate check (Paper or Electronic) for appropriate amount.
  • Credit Card use is encouraged for payments up to $4,000
  • Mail Paper Check to US Bank (St. Louis, MO)
  • Wire Transfer - If wiring the user fee, please include a $35 processing fee in addition to your payment.

Once the payment has been successfully processed by US Bank, and the Center has been notified, a letter will be faxed to your firm from FDA stating that your 510k is under review.

User Fee Information
  • User Fee hold letter will be issued if the payment has not been received or processed.
  • Always call or e-mail the user fee contact person if you believe you received this letter in error.
  • If 510(k) or 513(g) has been placed under review, a letter confirming this will always be faxed to the firm. If you do not receive this letter, please contact the user fee contact person.
User Fee Information
  • 510(k) and 513(g) User Fee is Per Submission.
  • Establishment Registration Submitted Annually (Oct. – Dec.)
  • Establishment Registration is a separate fee from the 510(k) and 513(g).

Premarket Notification [510(k)] Medical Device User Fees

Projected Fees, FY 2009 – FY 2012

FY09 – Standard Fee $3,693
Small Business Fee $1,847

FY10 – Standard Fee $4,007
Small Business Fee $2,004

Premarket Notification [510(k)] Medical Device User Fees

Projected Fees, FY 2009 – FY 2012

FY11 – Standard Fee $4,348
Small Business Fee $2,174

FY12 – Standard Fee $4,717
Small Business Fee $2,359

User Fee Contact Information

Small Business Determinations and General Questions:
DSMICA@fda.hhs.gov

User Fee Staff:
userfees@fda.gov
301-796-7200

Establishment registration:
reglist@cdrh.fda.gov
301-796-7400

Information Highway

FDA Homepage: www.fda.gov
Device Advice
Search Federal Register
Code of Federal Regulations (CFR)

Federal Food, Drug, and Cosmetic Act

Information Highway

CDRH Publicly Searchable Databases
This website contains over 15 publicly searchable FDA Databases.

510k Substantial Equivalence Decision-Making Process

Guidance & Flowchart