Learn how FDA handles a 513(g) request—from the 60-day statutory response clock to internal review steps and the structure of FDA’s determination letter, including device status, classification, and regulatory requirements.
One of the defining features of the 513(g) Request process is its relatively prompt turnaround. By law, the FDA is required to respond within 60 days of receiving a 513(g) request and the accompanying user fee. This 60-day timeframe is calendar days, not business days, and it starts counting from the date the FDA has a complete submission and confirmation of fee payment. In practice, FDA strives to issue the written response as close to this deadline as possible – many companies receive their 513(g) answer around the 55–60 day mark. The timeline is considerably shorter than typical review times for submissions like 510(k)s or PMAs, reflecting the more limited scope of a 513(g) review.
Once your request is logged in, it will be assigned to the appropriate FDA review division (e.g., cardiology devices, orthopedic devices, etc., depending on the device’s area of use). An FDA lead reviewer will examine your description and question, often consulting existing classification regulations, the product classification database, and possibly precedent determinations. They might also confer with subject matter experts or management for concurrence on the recommendation. Importantly, the FDA will not be reviewing any performance or safety data in this process – their focus is strictly on regulatory classification and requirements. This means they won’t be validating whether your device works or is effective; they are only determining how it should be classified under the law.
During this period, you will likely not hear from FDA unless something is amiss. The absence of communication is usually normal given the short timeline. If there were an issue (for example, if the request was not clear or some necessary detail was missing), FDA might reach out for clarification, but such instances are relatively rare if the submission was prepared well.
The culmination of the 513(g) process is an FDA response letter mailed (and possibly emailed) to you. This letter is typically a few pages long and contains several key pieces of information:
The letter often begins by referencing your request and summarizing what you asked – for instance, identifying your device and that you requested information on its classification and applicable requirements as per section 513(g). This assures you that FDA looked at the correct device and understood the inquiry.
The first major outcome you’ll see is whether FDA considers the product a “device” under section 201(h) of the FD&C Act. If FDA determines your product does not meet the definition of a medical device, they will explicitly state that. For example: “Based solely on the information provided, FDA has determined that the XYZ product does not appear to be a device as defined in section 201(h) of the Act.” In such a case, they often will conclude the letter there, since if it’s not a device, FDA’s device regulations wouldn’t apply (they may sometimes direct you to another Center if it appears to be regulated as something else, such as a drug or a tobacco product). This outcome essentially answers that no device regulatory requirements apply due to lack of device status.
If FDA agrees your product is a device, the letter will provide detailed classification guidance. According to FDA’s 513(g) procedures, the response will generally include the following for a device:
FDA often will mention if there is an existing FDA guidance document or enforcement policy for that device type. For instance, if your device type is one for which FDA has issued an Enforcement Discretion guidance (meaning they exercise discretion in enforcing certain requirements), the letter may cite that guidance. E.g., “FDA has issued a guidance document ‘Mobile Medical Applications’ indicating that certain low-risk apps of this type fall under enforcement discretion.” Similarly, they might reference if your device type has special controls guidance or recognized standards. This is incredibly useful as it points you to further reading on how to comply.
The letter will typically include standard caveats. It will remind you that this response is informational and not a formal classification decision. It does not authorize marketing – you will still need to go through the appropriate premarket process if one is required. FDA may also note that their feedback is based solely on the information you provided; if your device or its intended use changes, the classification could differ. Essentially, it’s a snapshot opinion. They often include a disclaimer like, “This response does not constitute a determination that your device is or is not safe or effective, nor does it constitute clearance or approval” (to reinforce that point).
Interestingly, many 513(g) response letters will suggest what to do with the information. For example, if a 510(k) is required, they might direct you to resources on preparing a 510(k). If they don’t address certain questions like testing, they might explicitly suggest using FDA’s Q-Submission (Pre-Sub) program for further feedback on those aspects. For instance, “FDA’s response to a 513(g) request will not address specific testing requirements. You may send a Q-submission to the appropriate review division to discuss testing recommendations.” This is a hint for you to pursue a Pre-Sub meeting if needed, which many companies do after getting the classification settled.
From the above, the outcomes generally fall into a few buckets:
FDA concludes your product isn’t a medical device. Outcome: You have no FDA device requirements (though ensure it doesn’t fall under another FDA category). This can be a relief in some cases, or it may push you to engage a different regulatory pathway (e.g., maybe it’s a drug or a supplement).
FDA identifies an existing device type that is low risk. Outcome: Your device is Class I (or a Class II that is exempt from 510(k)). You will not need to submit a premarket notification, but you still must follow general controls (like labeling requirements, good manufacturing practices, and device registration/listing). This is good news – it means a quicker path to market, just ensuring compliance with basic regulations.
This is very common. FDA finds a matching category and determines your device is Class II and needs a 510(k) clearance before marketing. Outcome: You’ll prepare a 510(k) submission demonstrating substantial equivalence to a predicate. The letter will often hint at what predicate or product code they aligned your device with, which is a valuable clue for your 510(k) preparation.
FDA might state the device appears to be Class III, which means a PMA is required. Sometimes this happens if your device is truly novel (no existing classification) or high-risk. Outcome: You face a lengthier approval process. However, if the device is moderate risk but just new, you might opt for a De Novo classification request to down-classify from Class III to Class I or II. FDA’s letter won’t explicitly grant a De Novo (since that’s a separate process), but identifying no existing class is essentially saying “currently Class III by default.” Sponsors can use that information to pursue a De Novo petition if appropriate.
In some instances, FDA might not be certain which regulatory framework applies if your product straddles categories (drug-device combination, for example). They may respond that the product may not be a device but could be something regulated by another Center, suggesting you contact the Office of Combination Products or submit a Request for Designation (RFD)[50]. While less common in 513(g) (since most people won’t file a 513(g) if they strongly suspect it’s a drug, for instance), it can happen if a device includes a drug component or similar. Outcome: You might need to pursue a formal jurisdiction determination via OCP.
Typical 513(g) outcomes are meant to guide your next steps. The response letter doesn’t solve everything, but it gives you a roadmap. If a 510(k) or PMA is required, you now know to start preparing those submissions (and you can plan for necessary testing, etc.). If no submission is required, you can focus on compliance and market entry preparations. We’ll cover the recommended actions after getting a 513(g) response in a later subpage, but generally, the outcome letter should be viewed as actionable regulatory intelligence.
It’s worth noting that the 60-day deadline for 513(g) is generally met by FDA. The process is relatively straightforward on their end, and because user fees are now collected for 513(g)s, FDA is funded to perform these reviews. Unlike some other interactions, 513(g) requests are not reported in FDA’s official performance metrics publicly, but the Agency tends to treat the 60-day statutory deadline seriously. On rare occasions, companies might experience a slight delay (due to workload or if the request needed additional info), but that is the exception, not the rule. If you haven’t heard back and the 60-day mark is approaching, one can politely follow up with the designated contact point (or check that the contact info given was correct in the submission).
In summary, when you file a 513(g), you can expect a prompt, focused response that gives you a clear outcome regarding classification and regulatory obligations. This timely answer allows you to move forward confidently in your development or marketing plans. The next subpage will contrast the 513(g) process and outcome with other FDA interactions like Pre-Submissions and 510(k) submissions, so you understand how each fits into the regulatory puzzle.
Received a 513(g) letter from FDA and need help understanding the implications? Contact ADBC CRO. Our regulatory experts can clarify the FDA’s feedback and guide you on the appropriate next steps, whether it’s preparing a 510(k) submission or adjusting your regulatory strategy.
