MDUFA: Medical Device User Fee Amendments Guide

The Medical Device User Fee Amendments (MDUFA) is a United States federal statutory framework authorizing the Food and Drug Administration (FDA) to collect user fees from medical device manufacturers and premarket applicants. Enacted in 2002 under MDUFMA, the program is reauthorized every five years through performance agreements between the FDA and industry. Operating under its fifth authorization cycle, known as MDUFA V, the framework pairs application and establishment fees with binding FDA review performance goals to accelerate evaluation timelines, modernize regulatory science, and enhance patient access to safe technologies.

When assessing requirements for what is a medical device, investigators and regulatory teams must account for MDUFA fee schedules and review milestones throughout development.

What it is and who runs it

As described on the official page on 2026-11-07, MDUFA is administered directly by the FDA, primarily through the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). User fee revenues provide dedicated funding enabling the agency to hire specialized scientific reviewers, upgrade IT platforms, and maintain predictable review timelines without lowering safety standards.

The current iteration, MDUFA V, was enacted under the FDA User Fee Reauthorization Act of 2022 (FUFRA) as part of the Consolidated Appropriations Act, 2023. MDUFA V covers the five-year statutory period running from October 1, 2022, through September 30, 2027. Under MDUFA V, the FDA committed to targeted performance metrics across premarket submissions while expanding initiatives in real-world evidence (RWE), digital health technologies, and pre-competitive partnerships conducted with groups like the Medical Device Innovation Consortium (MDIC).

Eligibility

Entities seeking commercial distribution of medical devices in the United States or lodging premarket regulatory filings are subject to MDUFA requirements, unless exempt by statute. MDUFA obligations apply across distinct categories as described on the official page on 2026-11-07:

Premarket Application Sponsors: Any commercial firm or research institution submitting a 510(k) Premarket Notification, De Novo classification request, Premarket Approval (PMA), Product Development Protocol (PDP), Premarket Report (PMR), Biologics License Application (BLA), or 513(g) Request for Information.
Device Establishments: Facilities that manufacture or process medical devices for U.S. distribution must pay an annual establishment registration fee under 21 CFR Part 807.
Small Business Determination (SBD) Program: CDRH administers the SBD program, which grants fee relief based on certified gross sales or receipts for the most recent tax year (including all domestic and foreign affiliates):
- Gross Receipts ≤ $100 Million: Qualifies for the Small Business Fee rate, offering substantial reductions (typically 50% to 75% discounts) on premarket applications such as 510(k)s, De Novo requests, and PMAs.
- Gross Receipts ≤ $30 Million: Qualifies for a full waiver of the fee for the sponsor’s first qualifying major premarket application (such as a first PMA, PDP, PMR, or BLA).
- Gross Receipts ≤ $1 Million: Qualifies for potential hardship waiver of the annual establishment registration fee if the firm demonstrates acute financial distress.
Statutory Fee Exemptions: Certain submissions carry no user fees under MDUFA. Federally sponsored research applications from state or federal agencies are exempt provided the device is not commercially distributed. Informational interactions such as the FDA Q-Submission program and 510(k) applications reviewed through accredited Third-Party Review organizations do not incur FDA premarket user fees.

What it funds or requires

MDUFA establishes a reciprocal agreement between industry applicants and the FDA, mandating operational requirements from sponsors while funding specific agency review functions:

What MDUFA Requires from Applicants:

Advance Fee Payment: Applicants must register in the online FDA User Fee System, generate a Medical Device User Fee Cover Sheet, and obtain a unique Payment Identification Number (PIN). Fees must clear before the FDA accepts the submission into substantive review.
Annual Facility Maintenance: Establishments must renew registration and pay the annual establishment registration fee between October 1 and December 31 for the upcoming fiscal year.
Annual SBD Re-Certification: Small business status does not renew automatically; eligible sponsors must submit Form FDA 3602 (domestic) or Form FDA 3602A (foreign) annually before filing fee-discounted submissions.

What MDUFA Funds at the FDA:

Targeted Review Timelines: MDUFA commitments fund review capacity to meet quantitative timeline goals under FDA medical device regulations and classification pathways. This includes formal decision goals for 510(k)s (typically 90 FDA days), De Novo requests (150 FDA days), and original PMAs (180 to 320 FDA days).
Infrastructure and Scientific Reviewers: Revenues support specialized review staff and technical portals, including the CDRH Customer Collaboration Portal (CCP).
Targeted Program Infrastructure: MDUFA V specifically funds resources for the Accreditation Scheme for Conformity Assessment (ASCA), the Total Product Life Cycle Advisory Program (TAP) pilot, and enhanced patient input frameworks.

Application or compliance steps

Research organizations and sponsors follow six compliance steps to ensure proper fee processing and prevent administrative submission delays:

Assess Small Business Eligibility: If qualifying based on gross receipts ($100 million or less), assemble corporate tax returns and affiliate disclosures. Submit Form FDA 3602 or 3602A via the CDRH Portal at least 60 calendar days before planned submission.
Receive Small Business Decision Letter: Upon approval, the FDA issues a decision letter with a unique Organization ID (Org ID) that unlocks reduced fee rates in the online portal.
Generate MDUFA User Fee Cover Sheet: Log into the FDA User Fee System, select the submission type, input the Org ID if applicable, and generate the official Cover Sheet.
Remit Payment and Retain PIN: Pay electronically via Pay.gov. Confirm that payment clears and record the unique Payment Identification Number (PIN).
Assemble Regulatory Package: Incorporate the Cover Sheet and PIN verification into the submission file. For 510(k) and De Novo submissions, format technical documentation using the mandatory eSTAR FDA submission template.
Track Milestone Clocks: Track substantive evaluation milestones via the CDRH Customer Collaboration Portal once the submission and fee are validated.

Typical timeline phases

Navigating MDUFA requires synchronizing submission schedules with federal fiscal cycles and statutory review stages:

Phase 1: Annual Fee Publication: The FDA publishes updated fee schedules in the Federal Register at least 60 days before the new federal fiscal year. Rates change annually on October 1 based on inflation adjustments and statutory revenue targets.
Phase 2: Annual SBD Filing Window: Eligible organizations submit SBD documentation in late summer to ensure approved discount status is active for the upcoming fiscal year.
Phase 3: Fee Payment Clearance: Fee cover sheets are generated and electronic payments cleared several days prior to application transmission.
Phase 4: Acceptance Screening: The FDA conducts Refuse to Accept (RTA) screening within 15 calendar days. Applications lacking verified user fee payment are placed on immediate hold.
Phase 5: Substantive Milestone Review: The file undergoes technical review against formal MDUFA V milestone clocks (such as 90 days for 510(k)s or 150 days for De Novo).

Common mistakes

Applicants frequently encounter avoidable compliance setbacks when navigating MDUFA requirements:

Submitting Before SBD Approval: Paying standard rates and submitting an application before receiving an SBD decision letter. The FDA does not issue retroactive refunds if an applicant pays the standard fee before small business qualification is granted.
Omitting Corporate Affiliates: Failing to report gross receipts of parent entities or corporate affiliates on Form FDA 3602, leading to qualification denial.
Assuming Static Fee Amounts: Budgeting across fiscal years using obsolete rate schedules. Because fees adjust each October 1, filings crossing fiscal years must budget for revised rates.
Confusing Establishment and Submission Fees: Conflating annual establishment registration with premarket application fees; these are distinct statutory requirements.
Submitting Files Without Cleared Payment: Submitting technical files before Pay.gov funds clear, triggering administrative holds and delaying review clocks.

Related programs

MDUFA operates alongside several complementary federal user fee programs and device regulatory mechanisms:

Program / Mechanism	Administering Agency / Center	Statutory Scope	Key Structural Distinction
MDUFA (Medical Device User Fee Amendments)	FDA CDRH / CBER	Medical devices, diagnostics, and establishment registrations	Reauthorized every 5 years; provides tiered small business discounts based on $100M/$30M gross receipts
PDUFA (Prescription Drug User Fee Act)	FDA CDER	Human prescription drugs and biological products	Enacted in 1992; assesses human drug application and prescription product program fees
BsUFA (Biosimilar User Fee Act)	FDA CDER	Biosimilar and interchangeable biologics	Funds biosimilar development meetings, application reviews, and biological product assessments
FDA Q-Submission Program	FDA CDRH / CBER	Pre-submission regulatory and scientific feedback	Statutorily fee-exempt interaction for clarifying clinical protocols prior to formal submission

FAQ

What does MDUFA stand for, and what is its primary role?

MDUFA stands for the Medical Device User Fee Amendments. It is federal legislation authorizing the FDA to collect user fees from medical device sponsors and manufacturing facilities to fund predictable, timely premarket reviews while upholding safety standards.

How does a startup qualify for small business user fee reductions?

A business qualifies by submitting Form FDA 3602 (or 3602A for foreign entities) along with certified tax returns to CDRH demonstrating that its gross receipts—including all corporate affiliates—were $100 million or less for the most recent tax year.

Do research pre-submissions or Q-Submissions require a MDUFA fee?

No. Standard Q-Submissions, including Pre-Submissions, Informational Meetings, and Study Risk Determinations, are entirely exempt from MDUFA user fees.

When does the current MDUFA V authorization cycle expire?

MDUFA V spans the five-year federal statutory period from October 1, 2022, through September 30, 2027, at which point it must be reauthorized by Congress as MDUFA VI.

Sources

U.S. Food and Drug Administration (FDA). “Medical Device User Fee Amendments (MDUFA): Fees.” https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa (read 2026-11-07).
U.S. Food and Drug Administration (FDA). “Medical Device User Fee Amendments 2022 (MDUFA V).” https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/medical-device-user-fee-amendments-2022-mdufa-v (read 2026-11-07).
U.S. Food and Drug Administration (FDA). “Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program.” https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program (read 2026-11-07).
U.S. Food and Drug Administration (FDA). “MDUFA Cover Sheets.” https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/mdufa-cover-sheets (read 2026-11-07).