Explore three case studies showing how companies used FDA 513(g) requests to clarify device status, classification, and submission needs—helping them avoid costly missteps and make confident regulatory decisions.
Nothing illustrates the value of a 513(g) Request better than real or representative examples. Below are three case study scenarios (with identifying details obscured) that demonstrate how different companies successfully leveraged 513(g) requests to navigate their development journey. These examples cover a range of outcomes – confirming device status, clarifying regulatory class, and informing next steps.
A digital health startup developing a mobile app and wearable sensor to guide meditation and stress relief. The product made general wellness claims (stress reduction) but was considering adding a claim related to mild anxiety management, potentially making it a medical claim. The team was unsure if FDA would consider their product a regulated medical device or an unregulated wellness device.
The startup submitted a 513(g) request with a full description of their app and wearable, explaining both the general wellness use and the potential medical claim. They directly asked, “Does our product, with the described claims, fall under FDA’s device definition? If so, what class and requirements would apply?”
Within the 60-day window, FDA responded with a letter stating that if limited to general wellness claims, the product did not appear to be a device, referencing the general wellness policy. However, FDA noted that if the product claimed to treat or mitigate anxiety (a medical condition), it would be considered a medical device. Based on the described functionality and intended use (with medical claims), FDA indicated the product in that scenario appeared to meet the definition of a device and would likely be classified as a Class II device, requiring a 510(k) for a biofeedback or relaxation therapy device.
This clarity was pivotal. Armed with FDA’s feedback, the startup made an informed strategic decision: they opted to launch the product without the medical claim initially, staying in the unregulated wellness space to gain market traction. They understood that adding the anxiety claim would trigger device regulation, meaning they’d need to conduct trials and submit a 510(k). Thanks to the 513(g) response, this decision wasn’t guesswork – it was based on FDA’s own guidance. The startup also communicated this plan to investors, who appreciated the clear rationale. In parallel, the company laid long-term plans to eventually pursue the medical claim (and thus a 510(k)) once resources allowed, now with confidence about the required classification and regulatory pathway. The 513(g) essentially drew a line for them: on one side, no FDA oversight; on the other side, Class II device – allowing them to innovate accordingly.
An established international device manufacturer working on a first-of-its-kind therapeutic device using focused ultrasound to treat migraines. No identical technology existed on the U.S. market. The company was unsure if this would be considered a Class II device with some predicate (perhaps under neurological stimulators) or treated as a novel Class III device requiring a PMA. This uncertainty affected their development plan and clinical trial strategy.
The manufacturer submitted a 513(g) request describing the device’s design and intended use (treatment of migraine headaches via non-invasive ultrasound neuromodulation). They provided details on how it differed from existing neurostimulators or TENS devices. Their questions were, “How will FDA classify this novel device? Is there an existing classification it falls under, and what premarket requirements (510(k) or PMA) will apply?”
FDA’s letter provided the crucial insight that, based solely on the information provided, the product did appear to be a medical device (no surprise there) and that it did not neatly fit into any existing classification regulation – indicating it was essentially a post-amendments device type that has not been classified. FDA stated that in such cases, by default, the device would be considered Class III and subject to the PMA requirement (since no regulation or predicate exists)[60][9]. However, FDA also noted that the sponsor could consider the De Novo pathway as an option to establish a new Class II classification if appropriate, given the moderate risk nature of the device (this was hinted at by referencing the absence of classification and the mechanisms to obtain one). They also identified an analogous device area in their databases (neurostimulators) but explained why the new device did not squarely fall under those, hence needing its own classification.
This feedback was invaluable for the company’s strategic planning. Knowing that FDA did not see an existing predicate or class for their device, they promptly initiated planning for a De Novo classification request. The 513(g) essentially warned them that a traditional 510(k) route was likely not available, preventing them from wasting time trying to find a predicate or preparing a 510(k) that would be doomed. Instead, they focused on gathering the kind of evidence needed for a De Novo (which is akin to a mini-PMA in rigor). They expanded their clinical trial to collect more safety and efficacy data to support a De Novo submission. Internally, the team secured additional budget and time in the project plan for this more involved regulatory process. Although a PMA was the default, the company, armed with FDA’s acknowledgment of the novel nature, pursued the De Novo to potentially get a Class II designation. Indeed, when they eventually submitted the De Novo request, they referenced the 513(g) response to show that they were following FDA’s guidance. The De Novo was successful, creating a new device classification – a result that might have been much harder if they’d attempted a 510(k) first and failed. In this case, the 513(g) acted as a reality check and guided them to the right regulatory strategy (De Novo) early, saving possibly a year or more of regulatory back-and-forth.
A mid-sized overseas manufacturer had a Class II medical device (a physiotherapy ultrasound device) already cleared in Europe under CE marking. They wanted to enter the U.S. market and assumed it would be a Class II device here as well, likely needing a 510(k). However, they noticed some similar devices in the U.S. seemed to be exempt from 510(k). There was confusion whether their particular device, which had some advanced features, required a 510(k) or if it could be exempt under an existing classification.
The company filed a 513(g) request detailing their device’s specs and intended use (pain relief and muscle therapy via ultrasound). They pointed out the classification they believed was relevant (an FDA regulation for “Ultrasound diathermy” devices) and asked FDA to confirm the device’s class and whether a premarket notification was required or if it fell under an exemption.
FDA responded that the device did appear to fall under the known generic type of “ultrasound physiotherapy device” which is a Class II device. They cited the specific regulation number and product code for that generic type. Importantly, FDA clarified that devices of this type require a 510(k) prior to marketing – they are not exempt. (In the company’s case, perhaps their confusion came from related devices that had different indications or power output which might have been Class I; but FDA’s letter made it clear their version was within Class II requiring clearance.) The letter also noted applicable requirements, like compliance with FDA’s performance standards for ultrasound (if any) and the need for FCC compliance for electronic radiation (as ultrasound therapy devices often have). They referenced an FDA guidance on such therapeutic devices, indicating what kind of information is typically expected in a 510(k) for them.
The manufacturer now had confirmation straight from FDA that a 510(k) was needed. This erased any internal debates or risky assumptions about skipping a submission. Strategically, they allocated resources immediately to preparing a robust 510(k) application, including conducting some additional biocompatibility tests that the cited guidance recommended. The 513(g) letter served as a supporting document when justifying timeline and budget to their executives for the U.S. launch – it was clear they had to go through clearance. Furthermore, knowing the exact product code and classification FDA would use for their device helped them identify a suitable predicate device (they looked up the product code’s database listing and found an example of a cleared device to use as a predicate). In essence, the 513(g) eliminated uncertainty and gave them a roadmap for U.S. entry. The company successfully obtained a 510(k) clearance the following year and cited the FDA guidance (noted in the 513(g) response) throughout their submission, aligning with FDA’s expectations from the start.
For companies considering a 513(g), these examples underscore how the investment in a classification Q&A can repay itself many times over in clarity and direction. The 513(g) response becomes a guiding document that can be referred to at board meetings, investor discussions, internal project planning, and in communications with FDA down the line.
Every device has its unique story. If you have a scenario and wonder if a 513(g) could help, or if you’ve received a 513(g) response and want to act on it, contact ADBC CRO. We can share insights from numerous real-world cases and guide you on applying 513(g) learnings to your specific situation, ensuring your device development remains on a successful track.
