Small Business Fee Waiver (for Medical Device Establishment Registration)

Small Business Fee Waiver (for Medical Device Establishment Registration) is sponsored by U.S. Food and Drug Administration (FDA). The FDA is granting a waiver of annual registration fees for device establishments that are small businesses, if FDA determines that paying such fee represents a financial hardship, starting on October 1, 2024.

Medical Device User Fee Amendments (MDUFA): Fees | FDA Skip to in this section menu Medical Device User Fee Amendments (MDUFA): Fees October 1, 2025, through September 30, 2026. Annual Establishment Registration Fee: $11,423 Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee and When to Register and List .

For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses qualified through the Small Business Determination (SBD) Program who demonstrate that paying the fee represents financial hardship as determined by the FDA. For more information, see the section on Small Businesses below.

Application Type Standard Fee Small Business Fee † 510(k) ‡ $26,067 $6,517 513(g) $7,820 $3,910 PMA, PDP, PMR, BLA $579,272 $144,818 De Novo Classification Request $173,782 $43,446 Panel-track Supplement $463,418 $115,855 180-Day Supplement $86,891 $21,723 Real-Time Supplement $40,549 $10,137 BLA Efficacy Supplement $579,272 $144,818 30-Day Notice $9,268 $4,634 Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) $20,275 $5,069 † Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.

For more information, see the section Small Businesses below. ‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Background and Legislation Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA) .

User fees were renewed in: 2007, with the Medical Device User Fee Amendments (MDUFA II) to the FDA Amendments Act (FDAAA) 2012, with the Medical Device User Fee Amendments (MDUFA III) to the FDA Safety and Innovation Act (FDASIA) 2017, with the Medical Device User Fee Amendments (MDUFA IV) to the FDA Reauthorization Act (FDARA) 2022, with the Medical Device User Fee Amendments (MDUFA V) to the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023.

MDUFA V will be in place from October 1, 2022 until September 30, 2027. And are slated to be reauthorized in 2028, with the Medical Device User Fee Amendments (MDUFA VI) . Under the user fee system, medical device companies pay fees to the FDA when they submit a premarket submission to market a new medical device in the U.S., and when they register their establishments and list their devices with the agency.

These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market. Submitting a Small Business Request (SBR): CDRH's SBD Program determines whether a business is qualified as a "small business" and eligible for a reduced fee for some types of CDRH submissions.

For program qualification and details on submitting an SBR, see Reduced Medical Device User Fees: Small Business Determination (SBD) Program .

Reduced Fees: Small businesses qualified through the SBD program with gross receipts or sales of $100 million or less are eligible for a reduced fee on: Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application (PMA), Biologics License Application (BLA), Product Development Protocol (PDP), Premarket Report (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information.

Application Waivers: Small businesses qualified through the SBD program with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), or Biologics License Application (BLA).

Annual Establishment Registration Fee Waiver: For FY 2026, certain small businesses qualified through the SBD program may qualify for a waiver for the registration fee if the business and its affiliates have gross receipts and sales of no more than $1 million, can demonstrate that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and have proof of a prior year’s payment of the registration fee.

Making a User Fee Payment For information about making a user fee payment for a medical device premarket application, visit the Medical Device User Fees webpage. For information about making a user fee payment for a medical device establishment registration, visit the Device Registration and Listing and Payment Process webpages.

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals User Fees and Refunds for De Novo Classification Requests User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications User Fees and Refunds for Premarket Notification Submissions (510(k)s) User Fees and Refunds for 513(g) Requests for Information Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments For other guidance documents, see MDUFA Guidance Documents .

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