Avoid pitfalls in FDA 513(g) Requests—unclear questions, missing details, vague intended use, fee issues, or poor organization. Learn best practices to ensure efficient review and accurate FDA feedback.
Even with a seemingly straightforward process, there are pitfalls that companies can encounter when preparing a 513(g) Request. Here we highlight common mistakes and how to avoid them, ensuring your request is processed efficiently and yields a helpful response.
The 513(g) mechanism is limited to questions of device classification and applicable regulatory requirements. A common mistake is including questions outside this scope. For example, asking “What testing does my device need for approval?” or “Is my device effective for its intended use?” in a 513(g) is inappropriate – those are not classification questions. Another misstep is asking FDA to “reclassify” an existing device type via 513(g). If you already know your device is Class II but want it to be Class I, 513(g) is not the route for that; FDA has a separate reclassification or De Novo process.
Keep your questions focused on classification. Phrase them to align with the statute: e.g., “Please provide the class in which this device has been classified and the requirements applicable.” Do not ask performance, testing, or clearance-related questions in a 513(g). If you have those, save them for a Pre-Submission. Remember, any inquiry that does not respect “the class… or requirements under the Act” will be considered outside the scope and FDA may ignore those parts or respond that they cannot address them via 513(g). By honing your question to exactly what 513(g) is meant for, you avoid confusion and ensure FDA can answer directly.
Some requesters provide too skimpy a description of the device, assuming FDA will “figure it out.” If key details about what the device is or how it works are missing, FDA might struggle to classify it correctly. For instance, failing to mention the device’s intended use or mode of action can lead to an incomplete answer or FDA needing to reach out for clarification.
Be thorough and clear in your device description (as detailed in the prior subpage). Include all relevant information: materials, technology, intended use, etc. Don’t assume FDA has prior knowledge of your specific product – describe it as if no one has seen it before. It’s better to err on the side of too much useful detail than too little. A good practice is to have someone unfamiliar with the product read your description – if they can’t understand what the device is or does, FDA might not either. Also, avoid unexplained acronyms or trade names; use generic descriptions that match how devices are described in FDA’s regulation and databases.
The device’s intended use drives classification. If you omit or vague-ify the intended medical purpose, FDA may not be sure which classification fits. For example, saying “this is a laser device” without stating what it’s for (surgery? cosmetic? therapy?) is a mistake. FDA classifies lasers differently depending on use (cutting tissue vs. skin rejuvenation are different categories). Similarly, not disclosing a key claim (like a diagnostic claim) can mislead the classification.
Clearly state the intended use and indications of your device in the request. If your device treats, diagnoses, prevents, or otherwise affects a disease or condition, say so plainly. Include the target patient group and context of use. If you have specific claims or marketing language in mind, include it or at least describe it. Don’t hide or downplay the device’s purpose thinking it might get a “lower” classification – be honest and upfront, since FDA will classify based on actual use. Providing labeling or advertising samples can help avoid this mistake by giving FDA the full picture.
A 513(g) request is intended for a single device (or product type) and its uses. Sometimes companies try to bundle multiple distinct devices or disparate questions into one submission to save time or fees. For example, asking about two different products in one letter, or asking both a device classification question and a drug classification question together. This can render parts of the request non-compliant with the 513(g) process. FDA might only answer one part or deem the request invalid and ask for separate submissions.
One device per request. If you have two devices, budget for two 513(g) submissions (and fees). Also, stick to the classification of that device – don’t tack on unrelated regulatory questions. The guidance explicitly states that multiple products require separate requests and fees. If your device has multiple potential uses (indications), you can include those in one request as they pertain to that device, but if the uses are vastly different and could change classification, ensure you describe each use scenario. If it’s too complex, consider separate requests for each scenario. In short: compartmentalize your inquiries to avoid overloading one request.
FDA will not start reviewing a 513(g) until the user fee is paid in full. A mistake is submitting the request package but failing to pay the fee or not correctly associating the payment. This results in delays – the 60-day clock doesn’t begin, and FDA may send a notification of non-payment. Another error is not obtaining a small business determination in advance and assuming you can pay the reduced fee without it (FDA will consider the fee unpaid if you attempt that without approval).
Always pay the fee before or at the time of submission, and include proof. Use FDA’s User Fee Cover Sheet system to generate the necessary identification, and ensure the payment (by credit card, wire, etc.) is confirmed. Attach the payment confirmation or the cover sheet to your submission as evidence. Double-check that the fee amount matches the current fiscal year fee for 513(g). If you are a small business, apply for the small business determination well ahead of time and wait for FDA’s grant of that status before submitting so you can confidently pay the reduced fee. If the fee isn’t paid, your request will sit idle indefinitely. This is an easily avoidable mistake with proper planning.
Sometimes submissions are sent in a haphazard manner – missing a cover letter, or missing key sections like device description, or lacking contact info. This can lead to FDA not having what they need to proceed. For instance, an unsigned or undated cover letter might be seen as incomplete, or forgetting to include your contact email could mean you miss correspondence.
Use a checklist (like the one provided in Subpage 4) to ensure all components are present and well-organized. Your submission should have a logical flow: cover letter -> detailed info -> any attachments (like labeling) -> fee confirmation. Clearly label each section. If submitting electronically, follow eCopy or eSTAR formatting guidelines so that FDA can easily navigate your files. Before sending, perform a quality check: is everything legible, included, and in a sensible order? Also verify that the contact information is correct and up to date; if FDA can’t contact you, it complicates the process.
This is more of a misunderstanding than a submission error, but it’s worth noting. Some may treat the 513(g) response as if it were an official device classification order or even an approval. For example, thinking “FDA said it’s Class II in the 513(g) letter, so we can market it now” – which is incorrect. Or using the 513(g) letter to claim FDA “approved” the device (which could be a regulatory violation in marketing).
Understand the limitations of a 513(g) response. FDA’s answer is an informal guidance not an approval. It even explicitly says it’s not clearance or a device classification decision for marketing purposes. So, avoid phrasing in your submission or subsequent communications that imply you are seeking an “approval.” You are seeking information. After you get it, plan to follow through with the actual required submissions (e.g., 510(k)). Internally align your team and management on this, so everyone knows the 513(g) is step 0, not the final regulatory milestone. This mindset will prevent inadvertent missteps like going to market without clearance or misrepresenting FDA’s letter.
In some cases, a 513(g) might not be the optimal path, but a company proceeds with it out of habit. For example, if the issue is actually one of jurisdiction (drug vs device), an RFD might be needed, not a 513(g) – submitting a 513(g) in such a case could waste time as FDA will respond that it’s not a device or refer you elsewhere, which you could have known. Or asking for classification when the classification is already obvious from the database (thus using time and money unnecessarily).
Do preliminary research and consult guidance before filing a 513(g). If your product is a borderline drug-device, consider contacting the Office of Combination Products first or filing an RFD rather than a 513(g). If your device seems to clearly match an existing device code and you have no doubt, a 513(g) might not be needed (unless you want extra confirmation). Essentially, use 513(g) strategically – not as a crutch for questions that have other defined processes or answers. When in doubt, a quick call/email to FDA’s Division of Industry and Consumer Education (DICE) can help; they often guide people whether a 513(g) is appropriate for their question. Leverage those free resources to avoid a misdirected submission.
Some may inadvertently (or deliberately) downplay certain aspects of the device in the 513(g) submission, thinking it will influence classification. For instance, not mentioning a therapeutic claim, or leaving out a component that could make it a combination product, etc. This is risky – FDA can only go by what you submit. If you omit critical information, you might get a classification that isn’t accurate for your actual intended product. That could lead you down the wrong regulatory path or require a correction later.
Some may inadvertently (or deliberately) downplay certain aspects of the device in the 513(g) submission, thinking it will influence classification. For instance, not mentioning a therapeutic claim, or leaving out a component that could make it a combination product, etc. This is risky – FDA can only go by what you submit. If you omit critical information, you might get a classification that isn’t accurate for your actual intended product. That could lead you down the wrong regulatory path or require a correction later.
By being aware of these common mistakes, you can proactively avoid them. Double-check your 513(g) request for clarity, completeness, and proper scope before submission. If needed, seek expert review (internally or via consultants) to catch any errors. A well-prepared 513(g) not only speeds up FDA’s response but also ensures you get the most useful guidance possible for your device.
Worried about potential pitfalls in your 513(g) request? Contact ADBC CRO. We offer meticulous review and consulting to help you avoid common mistakes, increasing the chances of a smooth 513(g) process and a helpful FDA response.
