What should you gather before an FDA 513(g) request?
If public FDA classification research still leaves your team unsure what generic type, device class, or submission bucket may apply, the next useful move is not another loose spreadsheet. Build a single-product, source-backed brief that already contains the intended use, device description, draft claims, similar-device clues, and the exact classification or regulatory-requirements questions you want answered. FDA's 513(g) process is built for that kind of formal question. It is not the same thing as FDA clearance, approval, or a final pathway decision, and this page does not make that decision for you.
Target query: what to gather before FDA 513(g) request.
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate suitability, substantial equivalence, reportability, complaint disposition, corrective and preventive action need, file closure, risk acceptability, compliance status, product safety, effectiveness, clearance outcome, inspection outcome, or legal obligations. We organize source-backed evidence for qualified RA/QA professionals or consultants to review.
Pre-production brief
Role
Founder or first RA/QA hire considering a formal FDA 513(g) request
Scenario
The team has already searched public FDA classification clues, but still does not know whether the next step should be a formal request for FDA's views on class and applicable requirements.
Concrete problem
They do not know what information belongs in a 513(g)-ready packet, what the request can and cannot answer, or how to avoid paying a fee for an unstructured question.
Available inputs
Product description, intended use and indications for use, draft labeling or claims, screenshots or links from the Product Classification Database and similar-device searches, and any prior internal notes about the likely U.S. submission path.
Useful output
- -A one-product 513(g)-ready brief with intended use, device description, draft claims, and exact FDA-facing questions.
- -A dated source ledger showing which public classification clues were checked before deciding whether to pay the fee.
- -A consultant handoff note separating what the request can answer from what still needs qualified judgment.
TrueMedDevice role
- -Organize public FDA-source evidence into a dated 513(g)-preparation packet.
- -Turn classification-clue research into a single-product question set with visible gaps.
- -Leave classification, submission pathway, product code strategy, and legal obligations with qualified reviewers.
Workflow: how to build a 513(g)-ready packet
1. Lock the intended use before you debate the pathway
FDA's device-determination page says teams should define the intended use and indications for use first. If those are still moving, a 513(g) request will inherit that ambiguity.
2. Record the public classification clues you already checked
Search the Product Classification Database, similar-device authorization records, and device listing references first. FDA explicitly points readers to those public methods before suggesting a formal 513(g) request.
3. Frame the request around one product and a small set of exact questions
FDA's 513(g) guidance says the request should seek classification information and or applicable regulatory requirements for a single product. Put the exact questions in the cover letter so the reviewer is not guessing what answer you need.
4. Assemble the four required content buckets before submission
FDA's guidance expects a signed cover letter, device description, description of use, and proposed labeling or promotional material. The device description can include materials, components, operational principles, energy used or delivered, and similar devices in U.S. commercial distribution if available.
5. Keep the scope frozen once you decide to file
After FDA has received the request and user fee, adding a new question, new use, or new technology is treated as a new 513(g) request. That is why the packet should be stabilized before the fee is paid.
6. Plan around the real calendar and submission mechanics
FDA says review begins once it has the submission and the user fee, intends to respond within 60 days of receipt, and may treat the request as withdrawn if additional information is requested and the submitter does not respond within 30 days. FDA also says 513(g) can be sent voluntarily through PreSTAR or as an eCopy.
What a useful answer should look like
What the public sources support directly
- FDA can give its views on generic type, class, and whether PMA, 510(k), or neither is required for that device type.
- A 513(g) packet should be built around one product.
- Voluntary submission paths include PreSTAR or eCopy.
- Some responses will not include a product code for devices that need a premarket submission.
What still belongs to qualified review
- Whether the product description is stable enough to justify filing now.
- How to word the FDA-facing questions for the specific device.
- What business risk is acceptable if the request delays another submission step.
- How any FDA feedback should shape the final pathway strategy.
The second list is an inference from the scope of the FDA sources above, not a direct FDA statement. The point is to keep evidence organization separate from regulatory judgment.
Source ledger
Every hard claim in this article maps to one of the official FDA pages below. The same ledger should travel with the packet you hand to qualified RA/QA or a consultant.
| Claim supported | Official URL |
|---|---|
| FDA's August 2024 513(g) guidance says the purpose of the guidance is to establish procedures for submitting, reviewing, and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device, and it was updated to address voluntary eSTAR submission. | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic |
| FDA's device-determination page says teams should define intended use and indications for use first, search existing classifications and similar devices, and consider a 513(g) request if they want a formal device determination or classification. | https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device |
| FDA's product-code guidance says a 513(g) response includes FDA's assessment of the generic type of device, device class, and whether PMA, 510(k), or neither is required, but a classification product code is not generally specified for devices that require a premarket submission. | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff |
| FDA's 513(g) guidance PDF says the request should contain a signed cover letter, a description of the device, a description of what the device is to be used for, and proposed labeling or promotional material for the device and, if available, similar legally marketed devices. | https://www.fda.gov/media/78456/download |
| The same guidance says a 513(g) request should seek classification information and or regulatory requirements for a single product, and that once FDA has received the request and user fee, a new question, use, or technology is treated as a new 513(g) request subject to an additional user fee. | https://www.fda.gov/media/78456/download |
| FDA's 513(g) guidance says FDA intends to issue its response within 60 days of receipt, and if FDA requests additional information and does not receive a response within 30 days, it may consider the request withdrawn. | https://www.fda.gov/media/78456/download |
| FDA's eSTAR page says 513(g) requests are within the voluntary use scope of eSTAR and that Early Submission Requests eSTAR, called PreSTAR, is the template used for Pre-Submissions, IDEs, and 513(g) requests. | https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program |
| FDA's eCopy page says 513(g)s may be submitted as eCopy or eSTAR on a voluntary basis, and FDA encourages eCopies or eSTARs where available for these submission types. | https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions |
| FDA's medical device user-fees page says requests for information under section 513(g) require a device user fee before FDA begins review, unless the applicant qualifies for a waiver or exemption. | https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees |
| FDA's FY 2026 MDUFA fee table lists the 513(g) fee as $7,820 standard and $3,910 for eligible small businesses for October 1, 2025 through September 30, 2026. | https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees |
Workload and cost framing
| Layer | What the source says | Operational meaning |
|---|---|---|
| FDA fee layer | FDA's FY 2026 MDUFA table lists the 513(g) fee at $7,820 standard and $3,910 for eligible small businesses. | The team should decide whether the uncertainty is expensive enough to justify a formal request rather than another round of informal internal debate. |
| FDA response window | FDA intends to issue a response within 60 days of receipt, and may withdraw the request if follow-up information is requested and the submitter does not respond within 30 days. | Filing without a stable packet can create calendar slip as well as fee waste. |
| Packet-preparation workload | Inference from the guidance above, not an FDA claim. | Expect roughly one focused working day if the intended use and claims are already stable, and closer to several working days if product description, claims, or similar-device clues still need cleanup before qualified review. |
FAQ
Does a 513(g) request give us a binding FDA clearance, approval, or final pathway decision?
No. FDA's 513(g) guidance describes the process as a request for information about device classification and applicable requirements, and FDA's product-code guidance says the response can identify the generic type, class, and whether PMA, 510(k), or neither is required. That is useful formal feedback, but it is not the same thing as completing whatever later submission or exemption path applies.
Will FDA give us a product code in a 513(g) response?
Not necessarily. FDA's product-code guidance says a classification product code is not generally specified in a 513(g) classification for devices that will require a premarket submission, although Class I exempt or Class II exempt devices may receive a product code as part of the recommendation.
Can we add a new use or new question after we submit the 513(g)?
FDA's 513(g) guidance says that once FDA has received the request and user fee, you may not modify the request by adding a new question, use, or technology. FDA would consider that a new 513(g) request subject to an additional user fee.
Does TrueMedDevice decide whether our product should go through 513(g), 510(k), De Novo, or PMA?
No. TrueMedDevice does not determine FDA classification, submission pathway, predicate suitability, substantial equivalence, compliance status, safety, effectiveness, clearance outcome, or legal obligations. We organize public-source evidence so qualified RA/QA professionals or consultants can review and decide.
Boundary statement
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness. We prepare a source-backed evidence pack from public FDA sources so qualified RA/QA professionals or regulatory consultants can review and decide.
Want this 513(g)-preparation packet built on your product?
We can turn your public FDA research into a dated question pack, source ledger, and consultant handoff note so the formal request decision starts from organized evidence instead of scattered tabs.
Review support only. We do not provide regulatory, legal, or compliance decisions. Final RA/QA, consultant, and manufacturer decisions remain with qualified reviewers.