Streamline your medical device development with ADBC CRO’s 513(g) Request for Classification services. Our expert team provides the best guidance to ensure your device is properly classified, helping you navigate the regulatory process efficiently and accurately.
An FDA 513(g) Request for Classification is a formal inquiry submitted to the FDA to obtain the Agency’s views on how a particular medical product is regulated. In essence, it allows a company to ask, “Is my product considered a medical device, and if so, what class is it and what regulatory requirements apply?” Under section 513(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will provide a written statement of the device’s classification (if one exists) and the applicable requirements within 60 days of receiving the request. This written response is not an approval or clearance, but rather FDA’s informed opinion based on the information provided by the requester. FDA explicitly notes that 513(g) responses are not formal classification decisions and do not constitute FDA clearance or marketing approval. Instead, the 513(g) process serves as a valuable guidance tool for manufacturers to understand how their product fits into the FDA’s regulatory framework.
The primary purpose of a 513(g) Request is to gain regulatory clarity at an early stage of product development. For many medical device startups, international manufacturers, or small-to-medium enterprises (SMEs), it may be unclear which device classification (Class I, II, or III) or regulatory pathway applies to an innovative product. By formally consulting the FDA via a 513(g) request, sponsors can get a clear answer on the device’s status and regulatory class. This can confirm, for example, if a novel health product is indeed considered a medical device under the law or if it might be outside the device definition (e.g. a general wellness product). If the product is a device, FDA’s 513(g) response will indicate the likely generic device type and class, and whether a premarket notification (510(k)), PMA, or neither is required to market that device. In other words, the FDA will outline what regulatory route is needed (if any) for lawful marketing. This early information is crucial for planning budgets, timelines, and development strategies.
A 513(g) response provides an official statement of how FDA views your product’s classification. This removes guesswork – you’ll know if your device is Class I (low risk), Class II (moderate risk), Class III (high risk), or not a device at all. Knowing the class guides what regulatory submissions are required (e.g. many Class I/II devices need a 510(k) unless exempt, whereas Class III often requires a PMA). This clarity helps you avoid pursuing the wrong submission type. For example, a startup might assume they need a 510(k) when in fact their product is novel and needs a De Novo or PMA – a 513(g) can prevent costly missteps by confirming the correct path.
By determining how the FDA classifies your device, you also gauge the regulatory burden early on. If FDA indicates your device is high-risk Class III (requiring clinical trials and a PMA), you can adjust your development plans, investor discussions, and timelines accordingly. Conversely, if FDA confirms your device is Class I or an exempt Class II device, you may not need a premarket submission, focusing efforts on compliance with general controls instead. In both cases, the 513(g) outcome informs your risk management and resource allocation upfront.
The FDA’s feedback via a 513(g) is grounded in the Agency’s understanding of current regulations and precedents. Having a written letter from FDA provides confidence to your team and stakeholders (investors, partners) that your regulatory strategy is sound. It is essentially official feedback that can back up your internal decisions. For startups, this can be particularly reassuring when pitching to investors or planning clinical studies – you can demonstrate that FDA has acknowledged how your product will be regulated. While non-binding, the 513(g) response is authoritative guidance that you can rely on for planning purposes.
Many companies have inadvertently run into compliance issues by marketing products under the wrong assumptions about classification. A 513(g) request helps avoid such pitfalls by clarifying if the product is subject to FDA device regulations. For example, an overseas manufacturer might assume their product is just a general wellness gadget, only to find later that FDA considers it a medical device requiring clearance. By using a 513(g) inquiry proactively, the manufacturer would learn the device is indeed regulated and can take proper steps before going to market. In cases where FDA responds that the product is not a device, that information is equally valuable – it means the company likely does not need FDA premarket approval to proceed (as long as no new medical claims are added). Either way, the company avoids the risk of non-compliance or unnecessary work.
Ideally, a 513(g) Request is made early in development or product planning, when there is uncertainty about how the device will be classified or what regulatory requirements will apply. FDA itself recommends considering a 513(g) whenever you’d like a formal device determination or classification from the Agency. By integrating a 513(g) inquiry into the early phases of your regulatory strategy, you can make informed design and planning decisions (e.g. whether to build your technical documentation for a 510(k) versus a PMA). It also allows you to allocate budget for necessary testing or quality systems appropriate to the device class. International firms entering the U.S. market often file 513(g) requests to confirm the U.S. classification of their product, which may differ from its classification elsewhere. This ensures there are no surprises and that the regulatory approach in the U.S. is aligned with FDA’s expectations.
While the 513(g) process is a powerful tool, preparing a clear and complete request is key to obtaining a useful response. Companies like ADBC CRO specialize in helping sponsors compile effective 513(g) submissions, ensuring that the FDA reviewer has the information needed to provide a definitive classification. In the following subpages, we will explore when to file a 513(g), how to prepare the request, what FDA’s responses look like, and how to leverage 513(g) outcomes in your regulatory journey. This guidance is especially valuable for medical device startups and international manufacturers who may not be fully fluent in FDA’s classification system and seek a confident path forward.
Need clarity on your device’s regulatory path? Contact ADBC CRO to discuss how a 513(g) Request for Classification can benefit your development program and to get expert assistance in preparing a successful submission.
