An FDA 513(g) response is a compass, not the finish line. Review the letter, align your team, plan required submissions, and engage FDA as needed. Use it as a living guide to steer compliance, strategy, and product development with confidence.
Getting the FDA’s 513(g) response letter in hand is an important milestone. It provides the classification and regulatory information you sought. But it’s not the end of the journey – rather, it’s a compass pointing you where to go next. In this section, we outline how to interpret the 513(g) response and the prudent next steps to take, so you can capitalize on the information and maintain momentum in your regulatory and product development process.
Upon receipt, read the FDA’s 513(g) letter thoroughly (likely multiple times) and ensure you understand every element of it. Identify the key outcomes: Did FDA classify the product as a device or not? If a device, what class and under what regulation/product code? Is a 510(k) required, or a PMA, or neither (exempt)? What other requirements or guidances did they mention? Make a checklist of these items directly from the letter. Often, the letter will enumerate points (as described in Subpage 5: class, submission type needed, other requirements, etc.). If anything is unclear – for instance, a cited regulation you’re not familiar with – look it up on FDA’s website (the CFR reference or product code database) to get more context. This letter is now a foundational document for your project, so treat it as such.
Convene your project team (regulatory, clinical, R&D, marketing, management) and communicate the findings of the 513(g) response. It’s crucial that everyone is on the same page regarding what FDA expects. If FDA said “Class II, 510(k) required,” then the team knows a 510(k) submission is on the critical path to market. If FDA said “not a device,” that’s a different conversation – you might pivot to focus on marketing without FDA constraints, but also keep an eye on not straying into device claims that could change that status. The outcome might affect business strategy: for example, if now confirmed as Class III, management might reassess timelines and funding (perhaps the device’s market entry will be later due to a PMA). Essentially, use the 513(g) result to update your regulatory strategy document and development plan. The earlier assumptions you had (if any) should be replaced with what FDA has indicated.
A 513(g) letter, by design, does not delve into how to fulfill the requirements of the classification. For instance, if FDA tells you a 510(k) is needed, they won’t specify what testing to do in the 513(g) response. If you identify areas where you need more FDA input – such as clinical study design, test protocols, or predicate selection – the recommended next step is to request a Pre-Submission (Q-Submission) meeting or written feedback. FDA explicitly encourages this: “FDA’s response to a 513(g) Request will not address specific types of testing… You may send a Q-submission to the appropriate review division for more specific information”[13]. Take that advice. For example, after a 513(g) confirms Class II, you might submit a Pre-Sub to ask, “We plan to conduct these bench tests and possibly a small clinical study for our 510(k) – does FDA agree with our plan?” By referencing your 513(g) outcome in the Pre-Sub, you show continuity and build on the established understanding. If the 513(g) letter named a guidance document or special controls, you could ask in a Pre-Sub how to best meet those guidelines. This sequential approach – 513(g) then Pre-Sub – is a powerful one-two punch to ensure you’re fully in line with FDA expectations.
Depending on the response:
Begin preparing your 510(k) submission. Use the product code/regulation from the letter to gather predicate device information (if not already known) – FDA likely aligned your device with a certain existing category, so identify a suitable cleared predicate in that category. Compile the necessary testing results (performance, safety, etc.) that demonstrate substantial equivalence. The 513(g) classification might also hint at specific special controls or standards; ensure you address those. Set a realistic timeline for submission, often factoring in any additional development work needed to meet requirements. Remember to budget for the 510(k) user fee (if not exempt). A tip: include a copy or reference of the 513(g) letter in your 510(k) cover letter or FDA submission cover letter – it can help the FDA reviewer connect the dots (this is optional, but can be useful if, for instance, the classification was unusual).
This signals a major undertaking. Initiate high-level planning for a PMA – typically this means well-controlled clinical trials, extensive manufacturing information, and a longer timeline. Likely you will want to engage in Pre-Sub meetings as mentioned, to nail down trial designs that FDA would accept. Consider whether a De Novo is an option (for a novel Class III by default device that might be down-classifiable). If you believe your device is appropriate for De Novo (moderate risk), start preparing that rationale; if not, set up PMA scaffolding (which includes an Investigational Device Exemption (IDE) if a trial is needed, etc.). The 513(g) response’s identification of no existing class can support your De Novo petition (by showing FDA’s acknowledgement that no classification exists). If heading for PMA, the 513(g) essentially confirms you must meet Class III general and specific controls – ensure your quality systems, documentation, and team are ready for the rigors of a PMA process.
Congratulations, you might not need a premarket submission. But you’re not done – Class I and II exempt devices still must comply with general controls (and in some cases certain limitations of exemptions). Next steps here would include implementing a Quality Management System compliant with FDA’s Quality System Regulation (21 CFR Part 820) since you’ll be manufacturing a medical device. You also need to register your establishment and list your device with the FDA before marketing (devices exempt from 510(k) still require establishment registration and device listing). Additionally, ensure labeling meets requirements (e.g., proper device labeling per 21 CFR Part 801, including any required warning or indication statements). Essentially, shift focus to compliance and preparation for marketing rather than submission prep. It’s also wise to monitor if any guidance or standards were noted – just because you’re exempt doesn’t mean you shouldn’t follow FDA guidance for things like cybersecurity, biocompatibility, etc., as applicable to your device type.
If FDA concluded your product is not a device, you have no FDA device regulations to follow – for now. Next steps depend on your product and business. If it’s truly outside FDA’s purview (e.g., a general wellness product, or maybe it falls under a different regulator), you should still ensure you remain in that lane. That means, if you continue development, avoid adding claims or features that could tip it into device territory unless you’re prepared to then comply as a device. Use the freedom from device regulation wisely, but also ethically (don’t overstate what the product can do medically). If FDA suggested it might be regulated by another Center (like a drug or a dietary supplement or a combination product), your next step is to engage that part of FDA or follow that regulatory path (e.g., contact CDER if it’s drug-like). In any case, keep the 513(g) letter on file; it’s a shield of sorts – if later someone questions why you didn’t go through FDA, you have documentation that you consulted FDA and they said it wasn’t required.
Use the 513(g) outcome to update your internal regulatory strategy document, risk analysis, and design and development plans. For instance, if now confirmed as Class II, update your design control documents to reflect compliance with relevant special controls or standards. If Class III, ensure your risk management documentation addresses the higher risk classification. It’s also a good time to review if any new regulatory requirements apply due to classification: e.g., if radiation-emitting, you might need to file a Form FDA-2877 or comply with 21 CFR 1002 (the 513(g) letter might mention radiation requirements if applicable). If combination product, coordinate with combination product regulations. Essentially, treat the 513(g) letter as an input to all relevant quality and regulatory processes in your company.
While 513(g) letters are not public, you might decide to share the outcome with key external stakeholders in certain ways. For example, with investors or board members, you can communicate “FDA has confirmed our device is Class II and requires a 510(k) – which aligns with our plan and we are moving forward accordingly.” This builds confidence that you have derisked the regulatory classification. If you’re in a partnership or co-development, share relevant portions of the FDA feedback with your partner to ensure alignment. However, be cautious not to misrepresent the letter. Do not use it in marketing – e.g., avoid saying “FDA has classified our device as safe” or any phrasing that sounds like an endorsement. The letter is primarily for your internal use. If needed (for instance in regulatory submissions or to answer an FDA reviewer’s question in future), you can reference it, but publicly it usually remains in the background.
Regulations and FDA perspectives can evolve. A 513(g) letter is current as of its date, but say a year later, FDA might reclassify some device types via new regulations, or new laws could change requirements. It’s good practice to keep an eye on FDA announcements related to your device type even after the 513(g). That said, the 513(g) gives you a solid foundation that likely won’t shift drastically in the short term. Maintain the letter in your regulatory files and perhaps add it to your Design History File (DHF) as evidence of regulatory consultation. Should you have turnover in staff, ensure the knowledge from the letter is passed on.
Finally, execute on the plan that the 513(g) response has guided you to. The true value of the 513(g) is realized only when you act on it. Whether it’s compiling a 510(k) dossier, designing a clinical trial for a PMA, or ramping up manufacturing for an exempt device, you can move forward with greater confidence that you’re on the right track. The fog of regulatory uncertainty has lifted, and while work remains, you have a clearer view of the path ahead. In any interactions with FDA that follow (Pre-Subs, submissions), it’s evident that you’ve done your homework – you sought classification clarity and are following through accordingly. This often leads to smoother reviews because you’re not fighting fundamental issues like “what is this product, and what pathway should it be on?” – that’s already settled.
Remember, the 513(g) response is guidance, not gospel. If down the road your product changes or you add new indications, you may need to consider whether the previous classification still holds or if a new 513(g) or discussion is warranted. But for the scope you presented, FDA has given their view. Use it as intended: a tool to facilitate compliance and smart decision-making.
By taking these next steps diligently, you ensure that the effort put into obtaining the 513(g) information translates into regulatory and commercial success. Many companies find that the 513(g) response letter becomes a north star for the subsequent year or two of development – refer back to it whenever there’s confusion or scope creep, to remind the team of what the agreed classification and requirements are.
Navigating what comes after a 513(g) can be as important as obtaining the letter itself. If you need assistance planning your next regulatory moves – from Pre-Submissions to crafting a high-quality 510(k) or PMA – contact ADBC CRO. We’ll help you leverage your 513(g) results and drive your project through the next phases of the FDA journey, towards a successful market entry.
