How to Complete FDA Form 3601: Medical Device User Fee Cover Sheet

FDA Form 3601, the Medical Device User Fee Cover Sheet, is generated online through the FDA’s Medical Device User Fee System and must accompany most premarket device submissions. It links your fee payment to your specific application, and until both the cover sheet and a cleared payment are on file, the FDA will not accept your submission for review.

Which Submissions Need Form 3601

Not every device filing triggers a user fee. The cover sheet is required for:

510(k) premarket notifications, including Traditional, Special, and Abbreviated
Original PMAs, along with panel-track, 180-day, real-time, and efficacy supplements and 30-day notices
Original De Novo classification requests
Product Development Protocols (PDP) and Premarket Reports (PMR)
Device-related Biologics License Applications filed through CBER
513(g) requests for classification information
PMA annual (periodic) reports for class III devices

Two common filings sit outside the fee system. A 510(k) submitted on behalf of an FDA-accredited third-party reviewer carries no user fee.¹ Humanitarian Device Exemption applications are also fee-free.²

FY 2026 Fee Amounts

These fees apply October 1, 2025 through September 30, 2026. Most are tied statutorily to a percentage of the base PMA fee under 21 U.S.C. § 379j.³

510(k): $26,067 standard / $6,517 small business
Original PMA, PDP, PMR, or BLA: $579,272 / $144,818
De Novo: $173,782 / $43,446
Panel-track supplement: $463,418 / $115,855
Efficacy supplement: $579,272 / $144,818
513(g) request: $7,820 / $3,910
PMA annual report: $20,275 / $5,069

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Numbers reset every fiscal year through a Federal Register notice published before October 1. Check the current MDUFA fees page before generating a cover sheet. Using last year’s amount leaves a balance and stalls the review.

Qualifying for the Small Business Discount

If your company and all its affiliates have gross receipts or sales of $100 million or less, you can qualify for the reduced fees shown above through the FDA’s Small Business Determination (SBD) Program.⁴

You apply by filing a Small Business Request (SBR) with CDRH. Starting August 1, 2025, all SBRs, for both U.S. and non-U.S. companies, use the new Form 3602N, which replaces the older Forms 3602 and 3602A.⁵

Sequence matters. If you file the application before the FDA has approved your small business status, you pay the full standard fee and the agency will not refund the difference. Get your Small Business Decision number in hand before you generate the cover sheet. SBRs for FY 2026 are accepted from August 1, 2025 through September 30, 2026.

Full Waivers

Beyond the small business discount, some submissions pay nothing at all.

First premarket application: A small business with gross receipts or sales of $30 million or less (including affiliates) gets a one-time waiver on its first PMA, BLA, PDP, or PMR.⁴
Pediatric-only devices: Applications for devices intended solely for pediatric use are exempt across 510(k), PMA, PDP, BLA, PMR, and De Novo. If you later add an adult indication through a supplement or new 510(k), that later filing pays the full fee as if it were an original submission.¹
Annual establishment registration: Small businesses with gross receipts of $1 million or less can request a waiver by demonstrating financial hardship and showing proof of a prior year’s registration payment.⁵

Generating the Cover Sheet

Form 3601 is created online at userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. There is no paper version; the portal builds the form from what you enter.⁶

Have this information ready before you log in:

Your company’s legal name and headquarters address
Your FDA Establishment Identifier (FEI), if one has been assigned
The name, phone number, and email of the person responsible for the submission
Your Small Business Decision number, if you have one

Select the submission type carefully. The portal calculates the fee based on that selection and any small business discount that applies to your account. Picking the wrong type creates a payment mismatch that holds up review.

When you confirm, the system issues a unique payment identification number beginning with “MD.” That number stays with your application through the entire review and appears in the upper right corner of the finished cover sheet. Download and print it, and keep the MD number for payment and any later correspondence.⁶

Paying the Fee

Starting in FY 2026, the FDA no longer accepts paper checks, in line with Executive Order 14247. Two options remain:⁶

Online payment by ACH eCheck or credit card at userfees.fda.gov/pay. This is the FDA’s preferred method.
Wire transfer to the U.S. Department of the Treasury, referencing your MD identification number. If you wire, add your bank’s wire fee to the amount sent so the FDA receives the full fee rather than the fee minus the bank’s charge.

Do not send the application until payment has fully cleared. The review clock does not start until Treasury has processed and posted the fee, and confirmation usually comes by email.

Submitting the Cover Sheet With the Application

Place a copy of the completed Form 3601 as the first page of the application package and of every copy you submit. Applications go to CDRH or to CBER depending on the reviewing center; the current mailing addresses are listed on the FDA’s MDUFA Cover Sheets page.⁶ Intake staff check the MD number on the cover sheet against the FDA’s internal payment records before assigning the submission to a reviewer.

Refunds Are Limited, Especially for 510(k)s

Refund rights depend on the submission type. The statutory authority to issue partial refunds when an application is withdrawn after filing applies to PMAs, premarket reports, and supplements, and does not extend to 510(k) submissions.⁷

For a 510(k), a refund is available only if you withdraw before the submission has been accepted for substantive review. That covers situations where the FDA holds your submission for a missing or invalid eCopy and you decide not to resubmit, or where your application fails initial acceptance and you withdraw rather than supply more information. Once a 510(k) has been accepted for review, the fee is nonrefundable even if you withdraw.

1
U.S. Food and Drug Administration. Medical Device User Fees
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U.S. Food and Drug Administration. Getting a Humanitarian Use Device to Market
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Office of the Law Revision Counsel. 21 USC 379j – Authority to Assess and Use Device Fees
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U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA) – Fees
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U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees – Small Business Determination (SBD) Program
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U.S. Food and Drug Administration. MDUFA Cover Sheets
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U.S. Food and Drug Administration. User Fees and Refunds for Premarket Notification Submissions