The U.S. Food and Drug Administration (FDA) allows eligible small businesses to reduce certain medical device application and report fees or obtain specific waivers under the Medical Device User Fee Amendments (MDUFA). These benefits are not granted automatically; the company must submit a Small Business Request, or SBR, to the Center for Devices and Radiological Health (CDRH) Small Business Determination program, along with documents proving its revenues and those of its affiliates.
What can a company obtain?
Eligibility depends on total revenues or gross sales in the most recent tax year, including affiliates, and on the type of benefit requested. The FDA sets the main thresholds as follows:
- Reduction of application or report fees: For companies whose revenues or gross sales, including affiliates, do not exceed $100 million. This reduction does not include the annual registration fee.
- Waiver of the first premarket application or report fee: For companies whose revenues do not exceed $30 million, provided that neither the company nor any of its affiliates has previously submitted a first application in the eligible categories.
- Waiver of the annual registration fee: For companies whose revenues or gross sales do not exceed $1 million and that demonstrate financial hardship, provided that they paid the registration fee in a prior fiscal year and registered under the same owner or operator number with the FDA.
The concept of affiliates includes a relationship in which one company controls, or has the ability to control, another company, directly or indirectly, as well as cases in which a third party controls both companies.
Important limitations on waivers
The first premarket application or report fee waiver does not apply to all types of applications; according to the guidance page, it covers Premarket Approval (PMA), Premarket Report (PMR), Product Development Protocol (PDP), and Biologics License Application (BLA), but does not cover 510(k) applications.
The FDA also explains that an annual registration fee waiver is not granted merely because revenues are low. The applicant must prove financial hardship under a clear and public standard, and the agency indicates that the condition it currently recognizes as meeting this standard is active bankruptcy. A company that has not paid the registration fee in a prior year is likewise not eligible to request the waiver, even if it meets the revenue thresholds.
Documents and submission method
All SBR applications must be submitted electronically, and applications sent by mail will not be accepted. The file generally requires:
- A completed and signed FDA Form 3602N.
- The company’s signed U.S. federal tax return, or a certificate stamped by the national tax authority in the case of foreign companies.
- The same tax documents for each affiliate, according to its location.
- Proof of financial hardship and proof of payment of a prior registration fee when requesting an annual registration fee waiver.
- Additional documents when needed, such as certified translations or evidence of a company name change.
The company must first identify its Org ID number in its User Fee System account. This number is separate from the employer identification number, registration number, or tax number, and a new number should not be created if the company already has an existing account. The company then completes the sections of Form 3602N, including Section III, which may require certification by the national tax authority for the company or its foreign affiliates, and uploads the form and documents through the CDRH Portal.
Deadlines and review cycle
The FDA states that applications for the following fiscal year are generally accepted beginning August 2, before the start of the fiscal year on October 1, and that the application window remains open until August 1 of the following year. Information for annual registration fee waiver applications should be submitted at least 60 days before the fee due date, set for December 31; the page identifies the period from August 2 to November 1 for this type of application.
The FDA aims to complete its review of an application within 60 calendar days of receiving it. The status can be tracked in the “Your Reviews” section of the CDRH Portal, and the agency also sends a letter stating whether the application was approved or denied. The status takes effect on October 1 or on the approval date, whichever is later, and expires on September 30 of the awarded fiscal year, meaning that the company must submit a new application each fiscal year.
What changes in practice for companies?
The key operational point is that a company’s eligibility does not transfer to another entity. If a company acquires an establishment that was previously considered a small business, or if a consultant submitted an application on behalf of a client, the original company’s or consultant’s determination cannot be used to obtain the reduction. The entity that will pay the fee and is listed as the applicant must itself be the holder of the approved SBR, and its information and Org ID number must match the application information.
The company should not pay the reduced fee before receiving its SBD number and approval. If the application is submitted to the FDA after the full fee has been paid, the agency will not refund the difference later if the company is determined to be eligible as a small business. The portal displays application statuses ranging from processing and screening to review, hold, or closure, with the option to communicate securely with the FDA through the messages tab.
For foreign companies, revenues must be reported in the local currency and in U.S. dollars, with the exchange rate used identified. If there is no national tax authority in the jurisdiction, alternative financial evidence and a signed statement may be submitted, and the FDA will review the file on a case-by-case basis.