Standardized service

FDA Small Business Application

Companies meeting the revenue threshold can apply for FDA small business certification, unlocking substantially reduced MDUFA user fees for 510(k) and other submissions. We prepare the forms and handle CDRH portal submission.

RegulatorU.S. FDA (CDRH)

Revenue Threshold≤ USD 100M gross receipts, incl. affiliates

FormsFDA Form 3602 / 3602A

DecisionTypically a few weeks

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What this service is

FDA Small Business Certification is a qualification established under the Medical Device User Fee Amendments (MDUFA): a company whose gross receipts or sales for the most recent tax year do not exceed USD 100 million — including affiliates combined — can be certified as a small business.

Once certified, the company pays reduced user fees for 510(k), De Novo, PMA, and other submissions. U.S. businesses use FDA Form 3602 and foreign businesses use Form 3602A; applications are submitted through the CDRH Customer Collaboration Portal.

MDUFAFD&C Act §738FDA Form 3602 / 3602A

Who needs it

Small and mid-sized device companies preparing 510(k) or similar submissions who want reduced FDA user fees

Foreign manufacturers (using the Form FDA 3602A channel)

Companies whose prior-year certification is expiring and who need renewal ahead of a new submission

Prerequisites and sequence

FDA Establishment Registration→Small Business Application

Combined gross receipts or sales of the company and all affiliates for the most recent tax year do not exceed USD 100 million.
FDA establishment registration is completed or in progress, with an Organization ID (Org ID) available.
Tax documentation for the most recent tax year is ready.

Who holds regulatory responsibility

The applicant is the company itself; the form is completed and submitted by the Official Correspondent identified at registration, who is responsible for the truthfulness of the reported revenue figures. We help prepare materials, complete the forms, and track portal status.

Materials we need from you

Tax documentation for the most recent tax year (foreign businesses provide the revenue evidence required by Form 3602A)

Organization ID (Org ID)

List of affiliates and their revenue information (if any)

Official correspondent details

Process

01
Verify that company and affiliate revenue meets the threshold
02
Download and complete Form FDA 3602 (U.S. businesses) or 3602A (foreign businesses)
03
Create the request in the CDRH portal and submit
04
Receive the automated FDA confirmation email and track review status
05
Obtain the small business certification for use in subsequent user fee payments

Deliverables

FDA small business certification outcome

Archived application materials with validity reminders

Timeline

With complete materials, certification typically arrives within a few weeks of submission, depending on FDA review progress.

Scope

What we provide

Eligibility verification
Form completion and application submission
Review status follow-up
Outcome archiving and renewal reminders

What is not included

The 510(k) or other submissions themselves (separate engagement)
Tax audits or preparation of revenue evidence documents
Dispute handling where eligibility conditions are not met

What usually follows

FDA 510(k) Submission

Common pitfalls

Failing to combine affiliate revenue when judging eligibilityThe threshold is measured on the combined gross receipts or sales of the company and all affiliates, capped at USD 100 million. Counting only your own entity can lead to filing without actually qualifying, undermining the certification.

Assuming the certification is permanentSmall business certification is granted per tax year; to keep reduced rates for later submissions you must re-apply. Paying reduced fees on an expired certification can be clawed back when the FDA reconciles.

Applying only when the submission fee is dueCertification takes FDA review time, typically a few weeks. Starting the application right before a 510(k) fee payment risks missing the reduced rate and paying the standard fee instead.

Foreign businesses using the wrong formU.S. businesses file Form FDA 3602, while foreign businesses must use Form 3602A with revenue evidence issued by their national tax authority. The wrong form or non-conforming evidence gets returned and delays certification.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

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FAQ

What is the small business revenue threshold?

The standard is gross receipts or sales of no more than USD 100 million in the most recent tax year. Affiliates' revenue must be combined, and the combined total must also stay within the threshold.

Can foreign companies apply?

Yes. Foreign businesses apply using Form FDA 3602A, providing revenue evidence issued by their national tax authority as the form requires. The process mirrors the U.S. business route (Form 3602).

Is the certification permanent?

No. Small business certification is granted per tax year; to keep the reduced rates for later submissions, re-apply. We recommend completing it before filing projects such as a 510(k) so the fee payment timeline is not affected.

Related services

510(k) SubmissionThe 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.Establishment RegistrationManufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.

Disclaimer

Certification is decided by FDA review. Thresholds and standards are subject to the FDA's current published rules; this is an application assistance service, not tax or legal advice.