513(g) Request for Information: Filing, Fees, and FDA Response

A 513(g) request for information is a written request that asks the FDA to tell you how it would classify your product and what regulatory requirements apply to it. The statute gives the agency 60 days to respond after receiving a valid request, and the FY 2026 fee is $7,820, or $3,910 for qualifying small businesses.¹ The authority sits in 21 U.S.C. 360c(g), which directs the Secretary to provide a written classification statement to any person who requests one.²

When to File a 513(g)

Use a 513(g) when you don’t know whether the FDA considers your product a medical device at all, or when you can’t tell which class it falls into. This comes up with novel technologies that blend features from existing product categories, and with software products whose regulatory status isn’t obvious. Rather than guessing whether you need a 510(k), a De Novo, or a full PMA, you can get a written answer before committing serious resources to the wrong pathway.

The request is narrowly focused. It answers what the product is and which regulatory bucket it goes in. It does not open a dialogue about what data you’ll need, how to design a clinical study, or whether your testing approach is adequate. That kind of back-and-forth happens through a Pre-Submission (Q-Sub). If you already know your device class and pathway but have questions about the evidence needed for clearance or approval, use a Pre-Submission. If you’re still trying to figure out whether your product is even regulated as a device, start with the 513(g).

What to Include in the Submission

The quality of the FDA’s answer depends heavily on the quality of what you send. A thin package produces either a vague response or a request for more information, which eats into your timeline.

Cover Letter

Identify the submission explicitly as a “Request for Information under Section 513(g)” in the cover letter so there’s no ambiguity. Include a table of contents and clear section headings. If you don’t have proposed labeling or can’t locate labeling for a similar marketed device, say so in the cover letter rather than leaving the gap unexplained.³

Device Description

The device description is the core of the package. Cover the physical characteristics of the device, its components, and the materials used. More importantly, explain how the device actually works. Diagrams, schematics, or photographs help the reviewer understand the product far more efficiently than text alone.⁴ Keep it clear and skip jargon that doesn’t help explain the device’s primary function.

Intended Use and Indications for Use

State the intended use separately from the physical description, along with the specific indications for use. Intended use describes the general purpose; indications for use narrow that to the specific medical conditions, patient populations, and clinical scenarios the device targets.⁴ The same physical device can land in different regulatory categories depending on the claims you make about it.

Labeling

Include any proposed labeling or promotional materials you’ve drafted, plus labeling from a similar legally marketed device if you can find one.³ The FDA uses these to evaluate whether your marketing claims line up with the classification you expect. Include any labeling related to patient use.

User Fees and the Small Business Rate

The Medical Device User Fee Amendments require payment before the FDA will review the submission. For FY 2026, the standard 513(g) fee is $7,820. Certified small businesses pay $3,910.⁵ The amounts adjust annually, so confirm the current schedule before filing.¹

Qualifying as a Small Business

To pay the reduced fee, obtain a Small Business Determination from the FDA first. Apply using Form FDA 3602, which requires your most recent federal income tax return along with returns for all affiliates. If any affiliates are outside the United States, you’ll also need Form FDA 3602A with certifications from foreign tax authorities.⁶ Eligibility runs on gross receipts and sales: businesses with combined gross receipts under $100 million (including affiliates) qualify for the reduced fee on most premarket submissions.

Watch the timing. If you submit your 513(g) before the FDA issues your Small Business Decision number, you pay the full $7,820, and the agency will not refund the difference even if you later qualify. Send Form 3602 well in advance and wait for the decision before filing. For FY 2026, the FDA began accepting small business requests on August 1, 2025.⁷

Cover Sheet and Payment

Generate a Medical Device User Fee Cover Sheet (Form 3601) through the FDA’s online system before you pay. Register with your Employer Identification Number (U.S. firms) or DUNS number (foreign firms), then answer the questions about your submission type. When you submit the form, the system generates a payment identification number that begins with “MD” in the upper-right corner of the cover sheet.⁸ You’ll need that number when you pay through the User Fee Payment Portal and when you include the cover sheet with your submission. The FDA won’t accept the filing without a valid cover sheet and confirmed payment.⁵

How to Submit

The FDA accepts 513(g) requests through the eSTAR system, which is voluntary for this submission type. For devices regulated by the Center for Devices and Radiological Health, submit through the CDRH Portal. For devices regulated by the Center for Biologics Evaluation and Research, use the Electronic Submission Gateway. Physical media sent to the appropriate Document Control Center is also accepted.⁹

Digital files have to meet the FDA’s technical validation standards. A package that fails validation won’t enter the tracking system. Once the FDA successfully receives your submission, you’ll get an acknowledgment letter with a tracking number.

The 60-Day Clock

The statute requires a written response within 60 days of the FDA receiving a valid request.² The clock starts when the agency confirms a complete submission with verified payment.

If your request is incomplete and the FDA can’t classify the product from what you’ve sent, the agency will contact you for more information. Here’s where things stall. If the FDA doesn’t receive your response within 30 days of that request, it may consider your 513(g) withdrawn and issue a notice of withdrawal.³ Front-loading a thorough submission matters. An information request doesn’t just delay your answer; it creates a deadline that can kill the whole filing.

What the FDA Response Tells You

When the FDA determines your product appears to meet the definition of a medical device, expect the response to identify the generic device type (the classification regulation your product falls under), the device class, and whether marketing requires a 510(k), a PMA, or neither. It will also note other applicable requirements and flag any enforcement discretion guidance documents for that device category. For products that emit radiation, the response will note the additional requirements that apply.³

If the FDA concludes your product doesn’t meet the statutory definition of a device, the response will say so. That can happen with wellness products, general-purpose software, or items that fall under a different regulatory category. In those cases, you may need to evaluate whether the product is regulated as a drug, biologic, or combination product.

What the Response Is Not

The FDA response is not a clearance, not an approval, and not a classification decision. It is the agency’s assessment, based solely on what you submitted, of how your product would likely be classified. It does not constitute final agency action.³

Two practical consequences follow. You still need to complete whatever premarket submission the response identifies before you can legally market the device. And if the regulatory picture changes after you receive your response (new classification regulations, updated product codes, reclassification of related devices), the 513(g) letter won’t shield you. It reflects the agency’s thinking at the time it was issued, not a binding commitment about future treatment.³

If You Disagree With the Classification

Under 21 CFR 10.75, any interested person outside the agency can request an internal supervisory review of a decision through the FDA’s chain of command.¹⁰ For CDRH decisions that are not section 517A decisions, the request must be received within 60 days of the decision date, addressed to the next organizational level above the person who made the decision, submitted electronically, and marked “Appeal: Request for Supervisory Review.” Send it to the CDRH Ombudsman at CDRHOmbudsman@fda.hhs.gov.¹¹

The review is based on the existing administrative file. If you bring new information that wasn’t part of the original submission, the agency will typically send the matter back down for reevaluation based on that new data rather than resolving it at the supervisory level.¹⁰ As a practical matter, if your disagreement stems from information you didn’t include, you’re often better off filing a new 513(g) with the additional detail than pursuing the appeal. Supervisory review works best when the reviewer misinterpreted material that was already in the file.

1
U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA) Fees
2
Office of the Law Revision Counsel. 21 USC 360c – Classification of Devices Intended for Human Use
3
Food and Drug Administration. FDA and Industry Procedures for Section 513(g) Requests for Information
4
Food and Drug Administration. CDRH Industry Basics – 513(g) Requests for Information
5
Federal Register. Medical Device User Fee Rates for Fiscal Year 2026
6
U.S. Food and Drug Administration (FDA). How to Complete Form FDA 3602
7
U.S. Food and Drug Administration. Reduced or Waived Medical Device User Fees – Small Business Determination (SBD) Program
8
U.S. Food and Drug Administration. MDUFA Cover Sheets
9
U.S. Food and Drug Administration. eSTAR Program
10
eCFR. Internal Agency Review of Decisions
11
eCFR. 21 CFR 800.75