Medical Devices
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
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
- Create User Fees Cover Sheet
- Payment Identification Number
- Fax to 301-847-8527 and include in your 510(k) submission.
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
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