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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Medical Device User Fees
  1. Premarket Submissions: Selecting and Preparing the Correct Submission

Medical Device User Fees

On this page:

Overview

Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Product Development Protocols (PDPs),  Premarket Reports (PMRs), Panel-Track Supplements, Efficacy Supplements, 180-day Supplements, Real-Time Supplements, 30-Day Notices/135-Day Supplements, Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), and Requests for Information (513(g)s). Effective October 1, 2017, FDA will require user fees to support De Novo requests. The appropriate device user fee must be paid for the above listed applications in order for FDA to begin its review, unless the applicant is eligible for a waiver or exemption.

Fees

Information on user fees is located on the MDUFA user fee page. The applicable fee corresponds with the date the FDA received the submission. Please note that the FDA will consider the submission incomplete and will not begin the review until the fee is paid in full. The FDA will announce the new fees for the next fiscal year in a Federal Register notice prior to the start of each fiscal year. Small businesses may qualify for a reduced fee. A small business is defined as a business (including affiliates) that reported $100 million or less of gross receipts or sales in its most recent federal income taxable year. The small business fee is 50 percent of the standard fee.

513(g)

Guidance on assessing user fees can be found in "Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information."

De Novo

Guidance on assessing user fees for De Novo requests can be found in "User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff."2

510(k)

Guidance on assessing user fees for 510(k) submissions can be found in "Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission."

PMA & BLA

Guidance on assessing user fees can be found in "User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff."

Exemptions and Waivers

The following exemptions or waivers apply for the user fees for Medical Devices regulated by submissions:

Category 510(k) PMA, PDP, BLA or Premarket Report (PMR) 513(g) De Novo
First application submission fee waiver No waiver One-time first submission fee waiver for a small business with gross receipts of sales <$30> No Waiver No Waiver
Any application from a State or Federal Government entity Exempt from any fee unless the device is to be distributed commercially Exempt from any fee unless the device is to be distributed commercially No Waiver Exempt from any fee unless the device is to be distributed commercially
Any application for a device intended solely for pediatric use Exempt from user fee.
Note: changing the intended use from pediatric to adult requires  the submission of a new 510(k) and is subject to user fees		 Exempt from user fee
Note: if the applicant obtains an exemption under this provision, and later submits a supplement for an adult use, that submission is subject to the fee in effect for an original PMA		 No Waiver Exempt from user fee
Third- party review Exempt from FDA user fee.
Note: the third-party charges a fee for its review		 Not eligible Not eligible Not eligible
BLA for product licensed for further manufacturing use only N/A Exempt from User fee N/A N/A

When to Pay

Payment must be received and processed at the time or before the date the application is sent. If the FDA receives an application without full payment of all required fees, the FDA will consider the application incomplete and will not begin its review.

How to Prepare Payment

  1. Determine the correct user fee that is required for the type of submission.
    Note: If the applicant qualifies as a small business, follow the instructions in the Guidance for Medical Device User Fee Small Business Qualification and Certification. Applicants that qualify will receive a Small Business Decision number. The Small Business Decision number must be provided on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. The FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
  2. Determine if a Medical Device User Fee Cover Sheet is required.  Please see table below.
    Application Type Type of Submission User Fee User fee coversheet
    required (FDA Form 3601)
    513(g) Original Yes Yes
    De Novo Original Yes Yes
    510(k) Traditional Yes Yes
    Special Yes Yes
    Abbreviated Yes Yes
    Third Party Review No No
    Any submission that meets the criteria for an exemption No Yes
    Supplement No No
    PMA Original Yes Yes
    Periodic Report (Annual) Yes No (Invoice)
    Panel Track Supplement Yes Yes
    Normal 180-day Supplement Yes Yes
    Real- Time Supplement Yes Yes
    30 Day Notice Yes Yes
    Manufacturing/Sterilization Site Change No No
    PMA Post Approval Study Labeling Update No No
    Special PMA Supplement: Changes Being Effected No No
    Trade Name Supplement No No
    Any submission that meets the criteria for an exemption No Yes
  3. Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) (see instructions in next section), if required.
  4. Send your payment with a completed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601) (see instructions below).
  5. Send your application with a completed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601).

Complete the Medical Device User Fee Cover Sheet

Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) online. The Medical Device User Fee Cover Sheet and instructions are available online.

Applicants must register to create a Medical Device User Fee Cover Sheet. To complete the registration process at least one of the following numbers specific to the organization is required:

  • Organization Number
  • Duns and Bradstreet Number (DUNS)
  • Employer Identification Number (EIN)

A Principal Point of Contact (PPOC) from the organization must also be identified to be responsible for validating users for security purposes.

After registration and creation of a user name and password, the applicant will receive a confirmation email, after which the cover sheet creation page can be accessed. A unique user fee Payment Identification Number will be generated on the cover sheet upon completion. Three copies of the completed User Fee Cover Sheet are required: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

Submitting Payment

Send a printed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601) with the payment. This must include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on the check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer. Payments should be sent to:

By Mail:
Food and Drug Administration
P.O. Box 979033
St. Louis, MO 63197-9000

By Courier:
If the check is sent by a courier, the courier may deliver the checks to:
US Bank
Attn: Government Lockbox 979033
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4013 with have any questions concerning courier delivery.)

By Wire Transfer:
Wire transfers are now processed through the Federal Reserve Bank of New York. The following information is required to remit a payment:

FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit Number or ABA: 021030004
Address:
Federal Reserve Bank of New York
TREAS NYC
33 Liberty Street
New York, NY 10045
Tel (212) 720-5000

Also include the User Fee Payment Identification Number from the Medical Device User Fee Cover sheet when sending payment by wire transfer.

Note: The bank or financial institution may assess a fee for sending a wire transfer.

If needed for accounting purposes, FDA's tax identification number is 53-0196965.

To avoid delay in the review of your application, you should pay the application fee at the time you submit your application to FDA. The FDA records as the submission receipt date the latter of the following:

  1. The date the submission was received by the FDA; or
  2. The date the Federal Reserve Bank of New York notifies the FDA that payment has been received.

Please note the Federal Reserve Bank of New York is required to notify the FDA within 1-working day, using the Payment Identification Number.

Guidance Documents

513(g) Guidance Document

De Novo Requests Guidance Documents

510(k) Guidance Documents

PMA Guidance Documents

Cross Cutting Guidance Documents

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