On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated August 1, 2018.
FDA’s final guidance reflects several new and updated considerations for small businesses seeking to reduce their submission and registration fees. On the whole, the guidance appears to add a few more restrictions to the application process without offering pragmatic solutions on existing requirements. Although it creates a new avenue to seek a registration fee waiver, it also shortens the application window to apply for a small business designation and may impact sponsors whose national taxing authority (NTA) refuses to fill out FDA’s form.
The Medical Device User Fee Amendments (MDUFA) require businesses to pay user fees for a wide range of filings, such as 510(k)s, de novo requests, premarket approval applications, and annual establishment registrations. These fees help to fund FDA’s review but they can be steep for small businesses, which is why MDUFA includes provisions allowing companies with gross receipts below a prespecified threshold to pay reduced fees or, in limited cases, no fees at all.
FDA last issued final guidance on this topic in 2018. Its final 2025 guidance is a mixed bag for businesses, creating a new—but extremely limited—avenue to avoid the annual registration fee while also tightening the application window for seeking reduced submission fees and potentially requiring stricter documentation from some international sponsors. It also introduces a new form, Form 3602N, which consolidates and replaces earlier Forms 3602 and 3602-A.
Here are the key changes and reminders:
- A new FDA form (Form 3602N). FDA released a new form, which consolidated and replaced earlier Forms 3602 and 3602A. The new form adds a section for businesses seeking a registration fee waiver. The form also allows a foreign country’s NTA to e-sign the form through Adobe. According to informal FDA feedback, the new Form 3602N is now required for all small business requests and there will be no grace period to use the older forms.
- A shortened window to seek reduced submission fees. Starting with fiscal year (FY) 2026, a business must file its request to qualify as a small business for the current FY by July 31st—60 days before the start of the next FY on October 1st. Previously, businesses could file until the end of the current FY and often were able to file and obtain the small business designation in the last few weeks of the FY. With respect to the current FY 2025, informal feedback from FDA suggests that a business may file a FY 2025 application in accordance with the prior guidance (i.e., a business may submit an application up until the end of FY 2025). However, while FDA may accept FY 2025 submissions in August and September of 2025, this does not ensure that FDA will render a decision before the FY ends.
- A registration fee waiver—but one that’s very difficult to obtain. Under the new guidance, a business may request a waiver of its current year’s registration fee if it can show that paying the fee will cause “financial hardship.” While this is not the only restriction on eligibility, it is the most notable because FDA currently only recognizes active bankruptcy as sufficient evidence of “financial hardship.” Other eligibility requirements include a 1 million USD cap on the most recent tax year’s gross receipts, a shorter application period, and having paid the fee and been registered with FDA in a prior FY. The registration fee waiver will consequently be unavailable to most businesses until FDA expands the type of circumstances that satisfy the “financial hardship” requirement.
- Flexible documentation where there is no NTA. Providing new flexibility, FDA will allow foreign businesses located in jurisdictions with no NTA to submit other evidence of their gross sales and receipts, such as end-of-year financial statements or shareholder reports. This may help smooth the process for businesses operating in jurisdictions without centralized tax administration.
- Stricter documentation requirements where there is an NTA. On the flip side, FDA now says that a certification from a NTA is required if a NTA exists. This reflects a change from prior practice and the 2018 final guidance, which allowed a foreign business to submit evidence of its gross receipts from the local government if the business could show that it was impossible to obtain the NTA’s certification on FDA’s form. Depending on how strictly FDA implements the new policy, this change could present challenges for businesses headquartered in, or who have affiliates headquartered in, a country whose laws or practices prohibit them from signing Form 3602N (e.g., policy against signing a form issued by another government, policy against signing forms written in a language other than the local language).
While FDA has implemented some significant changes to the small business program, most of the key features remain as they were:
- The threshold to qualify as a small business is still 100 million USD in gross receipts for the most recent tax year filed (summed across the requesting business and its affiliates).
- Eligibility for the “first premarket application/report waiver” is unchanged, including the gross receipts threshold (30 million USD) and the rules restricting eligibility when an affiliate previously submitted a premarket application/report.
- The definition of “affiliate” remains the same.
One topic that the new guidance does not discuss is how to handle businesses that were recently created (whether the requesting entity or an affiliate). Historically, FDA’s position has been that a tax return (or NTA certification) must be provided for the requesting entity and all its affiliates, without exception. This has caused problems for sponsors who created a new subsidiary within the current tax year because the new company has not had an opportunity to file its first tax return. According to FDA feedback given in this situation, the only way to effectively cure the problem is to dissolve the newly created company, or wait until a tax return is available to file the small business request. A practical solution for how to navigate this foreseeable situation, and similar scenarios where a tax return may not have been filed in recent years (e.g., dormant OUS companies), appears to still be an open issue between industry and FDA.
On the whole, FDA’s new guidance raises the bar for qualifying as a small business—in both process and substance—and obtaining relief from submission and registration fees. Businesses hoping to save on these fees in FY 2026 should start assembling their documentation now.
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