513(g) Request for Classification Information

1. Key takeaways

A 513(g) request is a request for information submitted to FDA under FD&C Act §513(g), asking the agency to confirm in writing the classification level of a device and the applicable premarket submission requirements. It does not produce a market authorization, but it yields a pathway conclusion with official force, making it the official confirmation channel for sponsors whose own classification analysis remains uncertain.

• The 513(g) resolves classification uncertainty, not pathway strategy; it answers what class the device is in, not which commercial route to choose.
• It is especially suited to products spanning several product codes, products blending multiple technologies, and products whose new technology fits no existing code.
• The FY2026 fee is USD 7,820 (small business USD 3,910), a fraction of the fees for formal premarket submissions.
• 513(g) is within the voluntary eSTAR scope and is prepared using PreSTAR.
• A Class III conclusion with no predicate redirects the program to PMA or a De Novo request, ideally before major spending begins.

2. Legal basis

The table below records the statutory basis of the 513(g) request, its FY2026 fee schedule, and its place within the voluntary eSTAR framework, verified in 2026.

3. Expert insights

Insight 1: The 513(g) solves classification uncertainty, not pathway selection. When the product classification database and 21 CFR 862 through 892 do not allow a sponsor to determine where its device belongs, the 513(g) provides an official classification conclusion rather than a commercial decision. It is particularly suited to three situations: products that span multiple product codes, products that mix several technological characteristics, and products whose new technology cannot be placed into an existing code. In each case, the value lies in converting internal doubt into an authoritative written answer.

Insight 2: The fee is far below that of a formal submission, making it a low-cost purchase of certainty. The FY2026 513(g) fee is USD 7,820 (small business USD 3,910). Set against the 510(k) fee of USD 26,067, the De Novo fee of USD 173,782, and the PMA fee of USD 579,272, it is an inexpensive means of locking down the pathway before committing to any of the larger investments. Few regulatory expenditures offer a better ratio of certainty gained to money spent.

Insight 3: The 513(g) and the Q-Sub Pre-Sub divide the question space between them. The 513(g) is a statutory information request procedure with a statutory fee and an official written conclusion; the Q-Sub is a meeting-based communication mechanism covering a wider discussion space, including clinical protocols and predicate selection. The two do not replace each other: where the question is which class we belong to, the 513(g) is the more direct instrument; where the question is whether our clinical protocol is acceptable, the Pre-Sub is the better fit.

Insight 4: A Class III conclusion demands an immediate turn in the pathway. If the 513(g) conclusion is Class III and no predicate exists, the program must move to a PMA or a De Novo request under FD&C Act §513(f)(2). The value of the 513(g) lies precisely in making that turn happen before major investment, when the schedule and the budget can still absorb it without collateral damage.

The common thread across these insights is that the 513(g) is a certainty instrument. It works best when the sponsor arrives with a complete, well-documented analysis of its own, because the agency can then respond to a precisely framed uncertainty instead of reconstructing the sponsor’s reasoning from scratch. It also works best when filed at the moment of maximum leverage: early enough that the answer still shapes the development program, but late enough that the technological characteristics and intended use described in the request are the ones the final product will actually carry. Sponsors who respect both timing and preparation convert a modest fee into the single most load-bearing document of their regulatory file.

It is equally worth noting what the 513(g) does not do. It does not clear the device, it does not exempt it from any requirement, and it does not commit the agency to a future review outcome. The conclusion is informational, and the sponsor’s obligations remain whatever the classification itself entails. Any internal reading that goes beyond the written answer is an overreach that later reviewers will not honor, so the document should be quoted exactly, in full, wherever it is used.

4. Practical recommendations

• Use the 513(g) only after the sponsor’s own classification analysis has been completed and doubt remains; do not file unprepared exploratory requests.
• Describe the product’s technological characteristics, intended use, and proposed product code clearly in the request to minimize back-and-forth exchanges.
• Prepare the request using the current PreSTAR version.
• Archive the official 513(g) conclusion as a citable basis for the subsequent dossier.
• Budget at the FY2026 fee of USD 7,820 (small business USD 3,910).

5. Verification checklist

• □ Sponsor’s own classification analysis completed, with the basis and remaining doubts recorded.
• □ 513(g) request states the product’s technological characteristics and intended use.
• □ Proposed product code indicated.
• □ Prepared using the current PreSTAR version.
• □ Budget prepared at the FY2026 rates (USD 7,820 / small business USD 3,910).
• □ Official conclusion archived and designated as the citation basis for the subsequent dossier.
• □ Timing of the request reviewed so that the described characteristics match the final product configuration.

Finally, the outcome of a 513(g) request should be communicated inside the organization with the same rigor as a submission decision. A Class I or Class II confirmation justifies the chosen premarket route and its budget; a Class III conclusion justifies a fundamentally different program and an immediate pause on spending decisions that assume a lighter pathway. Treating the written conclusion as an internal governance document, not merely a regulatory artifact, ensures that the certainty it purchased actually changes what the organization does next.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com