A 513(g) request asks FDA to identify the regulatory class and product code for a device whose classification is unclear. The request is submitted through the eSTAR portal, includes a device description and classification proposal, and typically receives a written response within 60 days. It is an informal opinion — not a clearance or approval — but it provides important guidance before investing in a 510(k) or De Novo submission.
When a medical device is genuinely novel or falls into a gray zone between existing product classifications, a 513(g) request is one of the most valuable tools available. Named after Section 513(g) of the Federal Food, Drug, and Cosmetic Act, this submission type allows a manufacturer to ask FDA: "What regulatory class does my device fall into, and what premarket pathway does it require?" The answer comes in the form of a written response from CDRH — typically within 60 days — that identifies the applicable product code, classification, and likely submission pathway.
Step 1 — Prepare the Device Description
The most important component of a 513(g) request is the device description. FDA needs to understand exactly what the device is and does before it can identify the correct classification. A thorough device description covers: the device's intended use (the general purpose for which the device is intended), the indications for use (the specific conditions or populations it is intended for), the device's design and components, the materials in contact with patients or users, and the mechanism of action or mode of operation.
Vague or incomplete device descriptions are the most common reason 513(g) responses are inconclusive or require follow-up. Draft the device description with the same level of specificity you would use in a 510(k) Device Description section. If the device has distinguishing features that differentiate it from existing classified devices, those features should be described clearly.
Step 2 — Research Candidate Product Codes and Predicates
Before preparing the request, search FDA's Product Classification database for existing product codes that might apply to your device. A well-prepared 513(g) request proposes a specific classification and product code — it is not an open-ended question asking FDA to do the research for you. Demonstrating that you have considered the available product codes and explaining why a particular code does or does not apply makes the FDA reviewer's job easier and typically produces a more useful response.
If there is a cleared predicate device (a 510(k)-cleared product with a similar intended use), identify it. If there are multiple potential predicates under different product codes, list them and explain how your device compares. If you believe no predicate exists and De Novo or a novel product code is the appropriate path, explain why.
Step 3 — Pay the User Fee
A 513(g) request is subject to an FDA user fee. The fee amount is set annually under MDUFA and is listed on FDA's user fee schedule. Current fee information is available directly from FDA's 513(g) user fee page. Payment must be made before or at the time of submission — FDA will not begin review without fee payment confirmation. The fee may be paid via FDA's electronic payment system, and a payment confirmation number is included with the submission.
Step 4 — Assemble and Submit Through eSTAR
As of 2023, 513(g) requests are submitted electronically through FDA's eSTAR portal. The eSTAR system guides the submitter through a structured submission format that includes the cover letter, device description, classification proposal, supporting documentation, and fee payment confirmation. Prior to eSTAR, submissions were submitted as paper-based eCopies; the eSTAR format has largely replaced this approach.
The cover letter must identify the submission as a 513(g) request, include the requester's contact information, reference the fee payment confirmation, and summarize the classification question being asked. Attach all supporting documentation — predicate device information, literature citations, performance data if relevant, and a draft labeling if available — as PDF attachments within the eSTAR submission.
Step 5 — Track the Submission and Respond to FDA Requests
After submission, FDA assigns a submission tracking number (an RZ or similar number) and routes the 513(g) to the appropriate CDRH division. FDA's MDUFA performance goal is to provide a substantive response within 60 calendar days for 90% of submissions. Most 513(g) requests receive responses within this window.
FDA may occasionally request additional information before providing a classification opinion. If FDA requests additional information, the response must be submitted promptly to avoid delaying the review clock. In some cases, FDA may offer to discuss the classification question in a Q-Sub meeting, which can be particularly useful for devices with complex or ambiguous classifications.
Step 6 — Review and Act on the FDA Response
The 513(g) response is a written letter from CDRH that identifies the device's likely regulatory class (I, II, or III), the applicable product code, and the expected premarket submission type (exempt, 510(k), De Novo, or PMA). The response is an informal FDA opinion — it does not constitute a final classification order, a clearance, or an approval. It is a regulatory road map that informs the next step.
Review the response carefully against your device description. If the classification identified is as expected, use the product code and classification information to structure your 510(k) or De Novo submission. If the classification identified is higher than expected (e.g., Class III instead of Class II), review the reasoning and consider whether the device description can be refined or whether a pre-submission (Q-Sub) meeting with FDA would help clarify the pathway before investing in a full submission.
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What must a 513(g) request include?
A 513(g) request must include: (1) a cover letter identifying the request type and fee payment; (2) a detailed device description covering intended use, indications, design, materials, and mode of operation; (3) a proposed device classification with a suggested regulatory class and product code; (4) predicate or similar device information supporting the classification proposal; and (5) any relevant performance data, labeling drafts, or literature citations. FDA may request additional information if the submission is insufficient to support a classification opinion.
How is a 513(g) request submitted to FDA?
513(g) requests are submitted electronically through FDA's eSTAR portal as of 2023, or via the older paper-based eCopy process. The submission package includes the cover letter, device description, classification proposal, and supporting documentation assembled into a single PDF or eSTAR submission. Fee payment is required at the time of submission. FDA assigns the submission to CDRH's Office of Product Evaluation and Quality (OPEQ) for review by the appropriate device division.
How long does FDA take to respond to a 513(g) request?
FDA's MDUFA performance goal for 513(g) requests is to provide a substantive response within 60 calendar days of receipt for 90% of submissions. In practice, most responses arrive within this timeframe. The response is a classification opinion letter — it is FDA's informal view of the device's classification, not a final classification order or a clearance. The 513(g) response does not authorize marketing; it informs the manufacturer's regulatory pathway decision.
Is a 513(g) response binding on FDA?
No. A 513(g) response is an informal FDA opinion on classification and does not constitute a final agency determination. FDA's position may differ from the 513(g) response if new information comes to light during a subsequent 510(k) or De Novo review. However, a well-documented 513(g) response that clearly identifies the applicable product code, predicate device pool, and regulatory class provides strong guidance for structuring a 510(k) submission and reduces the risk of a classification surprise during premarket review.