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Premarket Notification [510(k)] Review Fees
Posted Date:2018/11/14
Overview
On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 was signed into law. This law authorizes FDA to charge a fee for medical device product reviews. These fees apply to Premarket Approvals (PMAs), Product Development Protocols (PDPs), Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), certain supplements, and Premarket Notification 510(k)s.
The fee must be paid for the above listed applications, unless the applicant is eligible for a waiver or exemption. Small businesses may qualify for a reduced fee. Payment must be received on or before the time the application is submitted. If the applicant has not paid all fees owed, FDA will consider the application incomplete and will not accept it for filing.
Fees
Information on 510(k) fees are located in MDUFA III Fee page. The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.
FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 50% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.
Exemptions and Waivers
The following exemptions or waivers apply to 510(k) applications:
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Fee Exemptions and Waivers (No Fee for These)
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Category
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Exemption or Waiver
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Third-party 510(k)
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Exempt from any FDA fee; however, the third-party does charge a fee for its review.
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Any application for a device intended solely for pediatric use.
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Exempt from user fee. Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k). The new 510(k) is subject to the 510(k) review fee at the time of submission.
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Any application from a State or Federal Government entity.
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Exempt from any fee unless the device is to be distributed commercially.
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When to Pay
Payment must be received at the time or before the date you send your application. If FDA receives an application without full payment of all required fees, FDA will consider the application incomplete and will not begin its review.
How to Prepare Your Payment
1. Determine the correct user fee that is required for your submission type.
1. Note: If you believe you qualify as a small business, follow the instructions in the Guidance for Medical Device User Fee Small Business Qualification and Certification located on MDUFA III Fee page. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. 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. Complete the Medical Device User Fee Cover Sheet (see instructions in next section).
3. Send your payment with a completed copy of the Cover Sheet (see instructions below).
4. Send your 510(k) application with a completed copy of the Cover Sheet.
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.
You will need to register to create a Medical Device User Fee Cover Sheet. To complete the registration process, you will need one of these pieces of information:
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Organization #:
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123456
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Dun and Bradstreet Number (DUNS) #
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123456789
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Employer Identification Number (EIN) #
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123456789
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You will also need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.
After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.
Submit Your Payment
Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer. Send your payment to:
Also include your User Fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.
Note: Your 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.
Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the submission receipt date the latter of the following:
1. The date the submission was received by FDA; or
2. The date Bank notifies FDA that payment has been received.
Bank is required to notify FDA within 1-working day, using the Payment Identification Number.