Timing is critical for 513(g) requests. Filed early, they provide clarity on classification, borderline device status, or regulatory pathways. This proactive step guides testing, avoids costly missteps, and ensures your FDA strategy is aligned from the start.
Timing is critical when considering a 513(g) Request for Classification. The best time to file a 513(g) is early in your development or regulatory planning process – specifically, when you encounter uncertainty about how your product will be classified or what regulatory pathway to pursue. Submitting a 513(g) too late (for example, after you’ve already invested in a specific submission route) could diminish its value, whereas submitting it early can shape your entire strategy. In practice, many companies choose to file a 513(g) as soon as they have a fairly well-defined description of the product (its technology, intended use, and key features) but before conducting expensive validation studies or preparing extensive documentation for a 510(k)/PMA. Early clarity from FDA can prevent wasted effort and ensure you target the correct regulatory requirements from the start.
Not every device requires a 513(g) inquiry – many traditional devices have clearly established classifications. However, there are several strategic scenarios where a 513(g) is especially useful:
If your device is novel or doesn’t neatly fit into existing FDA classification regulations, a 513(g) can provide insight. For example, imagine a product that combines new digital technology with a medical purpose (like an AI-driven diagnostic tool). It may not be obvious whether it falls under an existing device category or perhaps strays into unregulated territory. In such cases, a 513(g) request allows you to directly ask FDA how the device will be classified. The FDA’s response will tell you if the product appears to match an existing generic device type and class, or if it’s a completely new type (which could default to Class III/PMA). Companies have used 513(g) queries for things like novel wearables, health software, or combination gadget/drug products to understand regulatory implications early. (If the product seems to span drug or device categories, FDA may even advise that a different process – like a Request for Designation via the Office of Combination Products – is more appropriate, rather than a 513(g).)
A common strategic use of 513(g) is when it’s unclear if a product is regulated as a medical device at all. Some products sit on the borderline of FDA’s device definition – for instance, a wellness app with minor health claims, or a hardware product intended for general health monitoring vs. medical diagnosis. In these cases, filing a 513(g) can yield a decisive answer on whether the FDA considers the product a device under section 201(h) of the FD&C Act. If the answer is “no, it’s not a device,” you’ve just saved yourself from an unnecessary regulatory submission and can proceed without FDA oversight (assuming you keep claims within non-medical bounds). If the answer is “yes, it is a device,” then the response will further classify it (e.g. Class I, II, etc.), so you know what regulations apply. This scenario is particularly relevant for startups in the digital health and wellness space, where the line between regulated and unregulated products can be thin. Using a 513(g) inquiry strategically protects you from inadvertently bypassing requirements or over-regulating a product that doesn’t need it.
Sometimes a company might be torn between two regulatory pathways and needs FDA’s input to decide. For example, consider a device that could either be seen as a diagnostic test requiring a De Novo or PMA, versus a wellness tool requiring no premarket submission. Or perhaps your device could be seen as a Class II with a predicate (hence a 510(k)) versus a Class III (hence a PMA) depending on interpretation. A 513(g) request can clarify FDA’s view on the device’s classification, which in turn clarifies the required pathway. If FDA responds that the device falls into Class II and is “510(k) required,” you know a 510(k) is the likely route. If they respond that no classification exists (post-amendment device type not yet classified), that implies a Class III (PMA) – though you might then consider a De Novo submission to down-classify if appropriate. In either case, the timing of getting this answer (well before you prepare the submission) is strategically invaluable. It lets you focus resources on the correct submission type and avoid pursuing the wrong one.
FDA expects companies to do some homework before filing a 513(g). Often, you can find a device’s class by searching FDA’s public databases (product classification database, 510(k) database, etc.) and reviewing guidance documents. A 513(g) becomes strategically useful after you’ve done this and still aren’t certain about classification. For instance, if you cannot find a clear predicate device or regulation that covers your product, or if multiple possible classifications exist, that is a good time to use the 513(g) process. It’s essentially leveraging the FDA’s expertise when public information doesn’t yield a clear answer. FDA’s own guidelines encourage that if you want a formal determination or can’t find your device’s classification, a 513(g) request is the way to go. Knowing when to escalate to a 513(g) (versus when the answer is readily available via databases) is part of strategic regulatory intelligence.
For medical device developers, especially startups and international firms new to the FDA system, a proactive 513(g) can be a cornerstone of regulatory strategy. It should be considered before critical decisions like clinical trial design or market entry plans are locked in. By timing the 513(g) appropriately, you can, for example, avoid designing a large trial under the assumption of a Class III PMA if FDA might actually classify the device in Class II requiring only bench and minor clinical testing for a 510(k). Conversely, if a 513(g) early on signals a PMA is needed, you can align your strategy to gather robust clinical evidence and perhaps engage investors with that information. Essentially, the 513(g) serves as a “reality check” from FDA at a juncture when you can still pivot and adapt cost-effectively.
Generally, one well-crafted 513(g) request per product should suffice to get your classification answer. Each request covers a single device (or device family) and its intended uses. Filing multiple 513(g)s for the same device is uncommon unless the product undergoes a fundamental change or new questions arise (for example, you add a major new intended use that might alter classification). If you significantly change your device or discover new information after an initial 513(g) response, you might consider submitting a new 513(g) or engaging in a follow-up Pre-Submission meeting (depending on the nature of the question). Strategically, it’s best to formulate all your classification-related questions in one 513(g) to get a comprehensive answer, because FDA will treat new questions or uses not included in the original request as a separate submission with a new user fee.
File your 513(g) early, when classification uncertainty exists and before committing to a regulatory path. Use it in scenarios where clarity is needed on device vs. non-device status, on which class/pathway applies, or when dealing with novel technologies. By doing so, you position your project to move forward on solid regulatory ground, backed by FDA’s written feedback. Many successful medical device developers view the 513(g) as a small upfront investment (in time and fee) that can prevent costly delays and detours later.
Unsure if it’s the right time to seek FDA feedback? Contact ADBC CRO for expert advice on when and how a 513(g) Request can strategically benefit your device development timeline.
