Understand the differences between FDA’s 513(g) classification requests, Pre-Submission meetings, and 510(k) submissions. Learn when to use each to guide strategy, reduce risk, and secure market clearance efficiently.
When navigating FDA processes, it’s important to use the right tool for the right purpose. Three common FDA interactions for medical device sponsors are the 513(g) Request, the Pre-Submission (Pre-Sub) meeting (part of the Q-Submission program), and the 510(k) premarket submission. Each serves a very different role. Here, we break down the differences in a clear manner:
Obtain FDA’s official view on the device’s regulatory classification and requirements. A 513(g) is essentially a question: “What is my device’s class and what regulatory path applies?” It’s used when you need clarity on classification or even whether your product is considered a device at all.
Typically used early in development or planning, before submitting any formal market applications. Ideal when classification is unclear or to confirm the regulatory pathway.
You submit a written request (with a user fee) containing a device description and your questions. FDA provides a written response in ~60 days outlining the class, applicable regulation, and whether a 510(k), PMA, or exemption applies. No meeting is involved; it’s a letter reply from FDA.
Focused on classification and applicable regulations only. FDA does not give detailed feedback on testing, performance data, or whether your device is safe/effective. It’s a high-level regulatory determination. Also, FDA’s answer is not binding or a final decision; it’s guidance based on current information (you still must formally submit a 510(k)/PMA to get marketing approval).
Yes, a 513(g) requires a fee (with small business reduction available).
An FDA letter with classification info. For example, “Your device appears to be Class II under product code ABC, and a 510(k) is required”. Or “Not a device” or other such statements. No certificate or clearance is given.
Great for definitive answers on “what is this product in FDA’s eyes?” Use it to avoid regulatory misclassification, plan submissions correctly, or reassure investors that you have FDA’s opinion on record.
Formerly known as the “Pre-IDE” meeting, a Pre-Submission (Pre-Sub) is a mechanism to get informal FDA feedback or guidance on specific questions prior to an actual submission. This can cover a range of topics: testing plans, clinical study design, regulatory strategy, or even questions about how to demonstrate substantial equivalence for a 510(k). It’s part of FDA’s Q-Submission program which includes various interaction types (Pre-Subs, informal meetings, etc.).
Often used mid-development, after you know the classification/path, when you are preparing for a 510(k), De Novo, IDE, or PMA and want FDA’s input on how to meet requirements. For example, once you know you need a 510(k), you might do a Pre-Sub to ask “does my test plan for biocompatibility look adequate?” or “which predicate does FDA recommend?” Pre-Subs can also be used early to confirm regulatory strategy, but if the sole question is classification, FDA typically prefers a 513(g) for an official answer.
You submit a Pre-Submission request (no fee) with background info and questions. FDA will schedule a meeting or provide written feedback, generally within 70–90 days (per guidance) for a meeting. It’s more interactive: you often have a teleconference or in-person meeting with FDA reviewers to discuss your questions.
Broad and informal. FDA can comment on your proposed study protocols, recommend additional tests, discuss potential regulatory hurdles, etc. You can ask multiple questions. One can even ask about classification in a Pre-Sub, but the feedback would be non-binding and informal, whereas a 513(g) gives a formal written classification stance. In fact, FDA sometimes might respond in a Pre-Sub that “for an official classification determination, consider submitting a 513(g)” if that’s a primary question. Pre-Sub feedback is advisory, not a decision, but it’s extremely useful to gauge FDA’s expectations.
No fee for Pre-Submissions (they are a free service under MDUFA, to encourage early communication). This makes them accessible, and companies often use multiple Pre-Subs throughout development.
Meeting minutes or a written response from FDA outlining their feedback on each question. You do not get any approval or official decision. FDA’s Pre-Sub responses are not binding, but in practice, they are very valuable indications of what FDA will expect in a future submission. If FDA said in a Pre-Sub “We agree with your test plan,” it’s likely they won’t object to it during the actual submission review, barring new issues.
Use Pre-Subs to de-risk your upcoming submission. It’s a chance to ask “Are we on the right track?” and to understand any concerns the FDA might have ahead of time. It can save time in the long run by avoiding surprises in a 510(k) or PMA review. For startups or international firms, it’s also a chance to build a rapport with FDA and better understand U.S.-specific expectations. Unlike a 513(g), a Pre-Sub is not about getting a classification answer (though you could ask classification as one question, it wouldn’t carry the weight of a formal 513(g) response). The two can be used in tandem: e.g., first do a 513(g) for classification, then a Pre-Sub for testing methods once you know what submission type is needed.
A 510(k) is a formal regulatory submission to FDA to obtain clearance to market a Class II (or some Class I) medical device. It demonstrates that your device is substantially equivalent to a predicate device already legally on the market. This is not a Q&A or feedback mechanism – it’s an actual application for permission to sell the device.
After development and testing are largely complete. A 510(k) is submitted when you are ready to have the FDA review your device’s safety/effectiveness evidence (bench tests, possibly clinical data, etc.) in comparison to an existing device. It comes later in the product development timeline, usually as one of the final steps before commercialization. You would only submit a 510(k) if you know your device requires it (often determined by its class and lack of exemption). Often, companies will have used Pre-Subs to refine what to include in the 510(k) before submitting it.
You compile a comprehensive dossier including device descriptions, labeling, substantial equivalence arguments, test reports, etc., following 21 CFR 807 and FDA’s 510(k) format. You pay a substantial user fee (much higher than a 513(g) fee) unless exempt or using a third-party review route. FDA has an acceptance review (Refuse-to-Accept) and then a substantive review period. The goal is clearance typically within 90 FDA review days, although with interactions (requests for additional information) the total calendar time is often longer.
Full review of safety/effectiveness via substantial equivalence. FDA examines all provided data – bench, animal, clinical (if any) – to decide if your device is as safe and effective as the predicate. They also verify you meet labeling requirements, any applicable special controls, etc. It’s a stringent review but narrower than a PMA (since you’re comparing to an existing product rather than proving new safety/effectiveness from scratch).
Yes, 510(k) submissions have a user fee (e.g., around ~$19k for standard in recent years, with ~50% discount for small businesses – exact fees change each fiscal year). There are also fee exemptions for certain cases (like device submissions by government entities, or some third-party 510(k) reviews have no FDA fee).
If successful, you receive an FDA clearance letter and your device is given a 510(k) number (which is made public in the FDA database). This clearance affirms your device can be legally marketed in the U.S. for the intended uses reviewed. If not successful, FDA may determine Not Substantially Equivalent (NSE), which means you cannot market, and you might then consider a De Novo or PMA path.
The 510(k) is the real deal – the actual regulatory approval (clearance) process. In contrast, 513(g) and Pre-Subs are advisory or preliminary. You wouldn’t submit a 513(g) or Pre-Sub in place of a 510(k); rather, you use them to make your eventual 510(k) stronger and more certain. A 513(g) might tell you “yes, you do need a 510(k) and here’s the predicate category,” and a Pre-Sub might help iron out what data to include in that 510(k). By the time you file the 510(k), ideally you have FDA’s earlier feedback and are confident you meet the expectations.
A cleared 510(k) is a public, official status – your device is now on the market legally as a Class II device with a specific indication. Neither a 513(g) response nor a Pre-Sub feedback confers any marketing rights; only the 510(k) (or other market authorization like PMA/De Novo) does.Full review of safety/effectiveness via substantial equivalence. FDA examines all provided data – bench, animal, clinical (if any) – to decide if your device is as safe and effective as the predicate. They also verify you meet labeling requirements, any applicable special controls, etc. It’s a stringent review but narrower than a PMA (since you’re comparing to an existing product rather than proving new safety/effectiveness from scratch).
These mechanisms are not mutually exclusive – in fact, savvy companies often use them in combination as part of a comprehensive regulatory strategy. For example: A startup with a novel device might first submit a 513(g) to confirm it’s Class II and needs a 510(k). Then, they might do a Pre-Submission to review their testing plans with FDA. Finally, they submit the 510(k) with confidence after incorporating FDA’s feedback. This staged approach leverages the strengths of each interaction. Conversely, skipping these early steps could lead to missteps, like preparing a 510(k) with the wrong predicate or missing tests – which could result in an FDA rejection or significant delays.
While this subpage focuses on 513(g), Pre-Sub, and 510(k), note that there are other pathways like PMA (Premarket Approval) for Class III devices and De Novo for novel moderate-risk devices. Each has its own process and potential for Q-Subs (Pre-Subs) or other interactions. But regardless of pathway, the concept of 513(g) vs Pre-Sub vs submission holds: 513(g) = “what is my device?”, Pre-Sub = “advise me on my plan”, and the submission (510(k)/PMA/De Novo) = “approve/clear my device”.
By understanding these differences, you can ensure you’re using the correct approach at each phase. If you need an official classification -> use 513(g). If you need guidance on how to test or what regulatory hurdles exist -> use Pre-Subs. And when you have all your data ready -> submit the appropriate market application like a 510(k). Using the right tool not only saves time and resources but also positions you as a knowledgeable sponsor in FDA’s eyes.
Not sure which FDA process you need or when to use it? Contact ADBC CRO. Our team will help you map out a regulatory game plan – from 513(g) requests to Pre-Submission meetings to successful 510(k) submissions – tailored to your product and business timeline.
