A Guided Tour Through the FDA's De Novo Program for Novel Medical Devices
Is the FDA De Novo Pathway the Appropriate Medical Device Regulatory Route for Your Device?
If you're developing a new medical device and haven't stumbled upon the FDA's De Novo process, you might be curious if it's the right move for your device. Here, we'll dive into defining a De Novo device, understanding the De Novo pathway, and figuring out if it's the right fit for your device.
What is the De Novo Program and Which Medical Devices Does It Embrace?
So, what's a De Novo program? The FDA's De Novo process serves as a regulatory avenue for innovative medical devices to secure marketing authorization as Class I or Class II devices. Via the De Novo regulatory approach, the FDA reviews device data to ascertain whether it meets the criteria for De Novo classification - offering almost minimal risk and being novel enough that it doesn't have an existing comparable device. A predicate device refers to a device that's already on the market and is equivalent to the device being submitted for approval. If the FDA accepts the De Novo request, the device will receive FDA clearance as a new Class I or Class II medical device.
Deciding if Your Medical Device fits the Mold for the De Novo Pathway
With numerous FDA regulatory pathways to consider, determining if a medical device meets the criteria for the FDA's De Novo classification pathway can prove tricky. Device creators must submit a De Novo application when there's no clear market comparator or the device isn't substantially similar to one already on the market. Evaluate your device first to determine if there are enough similarities to other devices in terms of purpose, design, technology, or intended use that could justify the FDA classifying your device under one of their existing classification categories. Next, consider your device's level of risk. Only Class I and Class II devices qualify for a De Novo submission. Devices classified as high risk (Class III) must undergo the rigorous PMA (pre-market authorization) submission process. To learn more about the FDA's device classification system, click here.
The Perks of Treading the De Novo Path
The FDA introduced the De Novo pathway in 1997, enabling companies to secure FDA approval for low- to medium-risk medical devices without a market comparator or a device that is substantially similar. This submission option presents manufacturers with lower fees when compared to a PMA ($132,464 vs. $441,547), as well as a quicker review period (150 days vs. 180 days). The device must still meet the FDA's safety, effectiveness, and good manufacturing practice standards for approval, but many developers find that the De Novo process boasts a less burdensome route to FDA authorization. Some businesses also appreciate a marketing edge from launching a novel device with a classification that no other device has received.
Potential Pitfalls of the De Novo Pathway
The FDA's De Novo pathway for novel medical devices can be long and costly. In 2023, the fee for an FDA De Novo vs. 510(k) is significant - a De Novo classification request is $132,464, while the fee for a 510(k) is $19,870. In terms of timing for a 510(k) vs. De Novo submission, the difference is substantial, with De Novo requests having a target review period of 150 days compared to 90 days for 510(k). Additionally, there is no guarantee that clearance will be granted; rejection risk remains a concern. The FDA may request supplementary clinical or nonclinical data through an Additional Information letter. They may also decline the request if they determine that a similar device has already been classified. If the request is granted, the new classification will nearly always come with special controls that will apply to the device as well as future devices using that device as a basis. Upon granting the classification request, the FDA will publish a notice of the classification order, including any special controls, for use in future premarket notification 510(k) submissions.
The Timeline for the FDA De Novo Process
A thorough understanding of the De Novo review timeline is crucial so that manufacturers can create a strategic submission plan and prepare when considering feedback. Following your submission, the FDA will examine the application for completeness and assess whether it can provide a reasonable assurance of safety and effectiveness. Depending on FDA input, medical device developers may need to gather additional clinical or nonclinical data and submit additional information beyond the initial submission. FDA review times vary, but the FDA aims to issue a decision about a De Novo request within 150 days, excluding any days during which the request was on hold if an Additional Information request was issued. Devices creators can expect decisions within 250 days after initial submission, although the review process will differ on a case-by-case basis.
We've got you covered. The FDA's De Novo pathway is just one of the regulatory pathways that medical device companies can employ to introduce their product to the US market. Knowing which devices are eligible, understanding the benefits and drawbacks associated with it, and deciding whether pursuing the De Novo pathway is the right move for your device is critical. If you're unsure about the right regulatory pathway for your medical device or how to patent a medical device, our team of regulatory compliance consultants can help you understand which strategy will be best for your device. Contact us today to learn more.
- The FDA's De Novo program serves as a regulatory avenue for innovative medical devices to secure marketing authorization as Class I or Class II devices, offered almost minimal risk, and lacking an existing comparable device.
- When deciding if a medical device meets the criteria for the FDA's De Novo classification pathway, device creators must evaluate their device first to determine if there are enough similarities to other devices in terms of purpose, design, technology, or intended use that could justify the FDA classifying the device under one of their existing classification categories.
- The De Novo process boasts a less burdensome route to FDA authorization, presenting manufacturers with lower fees, quicker review periods, and a marketing edge from launching a novel device with a classification that no other device has received.
- The FDA's De Novo pathway for novel medical devices can be long and costly, with significant fees for submission compared to a 510(k), substantial review periods, and no guarantee that clearance will be granted.
- In seeking regulatory compliance for a medical device, device developers can turn to health-and-wellness businesses and medtech companies for advice on the best regulatory strategy, which may involve the FDA's De Novo pathway, among other options.
