FDA Form 3602N is the single application a medical device business uses to request a Small Business Determination from the Center for Devices and Radiological Health, which unlocks reduced (and in some cases waived) medical device user fees. Since August 1, 2025, this one form has replaced the older Forms 3602 and 3602A and covers both U.S. and foreign businesses. You complete it, attach the required financial documentation, and submit it electronically through the CDRH Customer Collaboration Portal. Paper filings are no longer accepted.1Food and Drug Administration. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
File it before you file any premarket submission. The FDA will not refund the difference between the standard fee and the small business fee once a submission has been received, so the determination has to be in hand first.2Food and Drug Administration. Medical Device User Fees
Which Threshold You’re Certifying To
Form 3602N asks you to certify that your combined gross receipts or sales for the most recent tax year fall at or below one of three thresholds. Each unlocks a different benefit:
- $100 million or less: reduced premarket submission fees on 510(k)s, PMAs, De Novo requests, and other covered submissions.
- $30 million or less: on top of reduced fees, the fee is waived entirely on your first PMA, product development protocol, premarket report, or biologics license application, provided your business has never previously submitted one of those application types.
- $1 million or less: you may qualify to have your annual establishment registration fee waived, if you can also demonstrate financial hardship and have paid the registration fee in a prior fiscal year.
Check every tier that applies in Section I. State the gross receipts figure in U.S. dollars; foreign businesses converting from another currency should use the Treasury Reporting Rates of Exchange for the relevant period.
How Affiliates Change the Math
The FDA counts every affiliate’s gross receipts toward your total. An affiliate is any business entity that controls yours, that yours controls, or that shares common control with yours through a third party.3Office of the Law Revision Counsel. 21 U.S. Code 379j-51 – Definitions Parent companies, subsidiaries, and sister companies under the same corporate umbrella all count.
The practical effect: a small subsidiary of a large multinational cannot claim small business fees on its own. If the parent and its other subsidiaries together earn more than $100 million, the subsidiary does not qualify no matter how little it earns standing alone. You list every affiliate in Section II with name, country, taxpayer ID, and gross receipts. Line 21 rolls up the total across your business and all affiliates, and that combined figure is what the FDA measures against the thresholds.
Filling Out the Four Sections
Download the current PDF from the FDA’s forms page. The form has four sections, and not everyone completes all of them.
Section I: Business Information and Certification
Enter your business name, address, and contact details. Box 4 identifies the official correspondent, who will be the primary point of contact and the only person able to view the request’s status in the CDRH portal.4Food and Drug Administration. Send and Track Medical Device Premarket Submissions Online: CDRH Portal Choose carefully. Delegate access is not yet available.
Section I also carries the formal certification. You check the applicable threshold, then sign and date. The certification warns that false statements can result in criminal penalties under 18 U.S.C. ยง 1001, which carries fines and up to five years in prison.5Office of the Law Revision Counsel. 18 U.S. Code 1001 – Statements or Entries Generally Accuracy in the financial figures matters here.
Section II: Affiliate Information
List every affiliate, up to 20 entities, with name, country, taxpayer ID, and gross receipts for the most recent tax year. Line 21 totals your own business plus all listed affiliates. If you have no affiliates, leave the affiliate lines blank but still enter your own business on the first line so the total reflects your standalone gross receipts.6Food and Drug Administration. FDA Form 3602N – MDUFA Small Business Request
Section III: National Taxing Authority Certification
Non-U.S. businesses only. If your business or any affiliate is based outside the United States, a National Taxing Authority must verify the gross receipts for each non-U.S. entity, providing the entity’s name, taxpayer ID, physical address, gross receipts for the most recent tax year, reporting period dates, and the converted U.S. dollar amount. Complete a separate Section III for each non-U.S. affiliate listed in Section II.
If your jurisdiction has no National Taxing Authority, the FDA will accept alternative evidence, such as end-of-fiscal-year financial statements or shareholder reports, and review it case by case. Any document in a foreign language should be accompanied by a full English translation with a signed certification from the translator stating their competence and that the translation is accurate.
U.S. businesses skip Section III and instead submit completed, signed, and dated U.S. federal income tax returns for the most recent tax year.
Section IV: Registration Fee Waiver Request
Complete Section IV only if you meet all three conditions: combined gross receipts on Line 21 of $1 million or less, a demonstrable financial hardship (such as evidence of an active bankruptcy), and payment of the establishment registration fee in a prior fiscal year. List the facilities you want covered. Everyone else leaves this section blank.
Submitting Through the CDRH Portal
Since November 1, 2024, small business requests must be submitted electronically through the CDRH Customer Collaboration Portal at ccp.fda.gov. Mailed paper submissions are not accepted.
- Create an account at the portal. Identity verification uses Okta, so expect registration and password-reset emails from an @okta.com address.
- Upload your completed Form 3602N along with supporting tax documentation, any Section III certifications for foreign entities, and any alternative financial evidence.
- Submissions received before 4 p.m. ET on a business day process the same day; anything after 4 p.m. ET processes the next business day. You will get an email confirming receipt.
The portal shows near-real-time status. If there are issues, the FDA sends a message through the portal and you reply through the same system. Only the official correspondent named in Section I can view the request.
When to File and How Long It Lasts
The FDA begins accepting requests for the upcoming fiscal year on August 1. For FY 2026, the window runs from August 1, 2025, through September 30, 2026. If you are seeking the registration fee waiver and your facilities are already actively registered, the deadline is tighter: October 31, 2025, for FY 2026.
A Small Business Determination is valid only for the fiscal year you applied for (October 1 through September 30). Renew it each year by filing a new Form 3602N. Because the FDA will not refund the standard-to-reduced fee difference after a submission is received, file 3602N well before any planned premarket submission and leave enough lead time for review.
When review is complete, the FDA sends a message through the portal indicating whether your business qualified. Include the Small Business Decision number on every premarket submission for the rest of that fiscal year to receive the reduced fee.