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Is the De Novo regulatory pathway a viable option to get your medical device to market?
De Novo has been around for a couple of decades now, although it’s still fairly underutilized when compared to other FDA pathways. This trend is changing though, as more companies look to this method for getting their medical devices to market.
How is De Novo different from the 510(k) route? While devices using the 510(k) pathway rely on predicate devices for proving substantial equivalence to a previously marketed device, De Novo begins with a completely clean slate. With no equivalence criteria required, De Novo uses a risk-based approach to assessing medical devices.
Could De Novo be the right pathway for your medical device? Here’s what you should know:
Should you use the De Novo pathway? First of all, you need to know which types of devices qualify for De Novo. In general, it is companies with a device that doesn’t qualify for the 510(k) pathway due to it being considered a “novel” device. In this case, there is no predicate available on the market so you would need to build a new case for why and how the device is safe and effective for public use.
Ordinarily, device types that involve any type of serious risk to the end user for which FDA has never classified before would be designated as Class III devices. However, the De Novo pathway was created to provide a way for devices to avoid the extra red tape that’s necessary for the highest risk devices.
FDA is cognizant of the resources it needs to devote to lengthy reviews of Class III devices, and De Novo provides an alternative. As the FDA’s De Novo guidance document states:
If a person believes their device is appropriate for classification into Class I or Class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510(k) and NSE (hereafter “Direct De Novo”).
Additionally, you may be able to take the De Novo route if your device already underwent a 510(k) review with a determination of “not substantially equivalent” (NSE):
For devices that have already undergone 510(k) review, FDA will consider a De Novo request if the device has been determined to be NSE due to: (1) the lack of an identifiable predicate device, (2) a new intended use, or (3) different technological characteristics that raise different questions of safety and effectiveness. Devices that have been found to be NSE due solely to performance data that is inadequate to demonstrate substantial equivalence (SE) would generally be ineligible for the De Novo classification process.
So the short answer is, if you have a novel device that isn’t considered high-risk and ineligible for 510(k) clearance due to NSE, then De Novo is likely the right pathway for you. Your only other option would be the premarket approval (PMA) pathway, which is designated for all Class III devices and is a much more lengthy and costly process.
We hosted a webinar covering the De Novo pathway to help medical device companies determine whether they should use it and key considerations to note. You can access the on-demand recording and slides by clicking the link above to access the detailed discussion on the topic.
In a sense, more work is involved with a De Novo submission than a 510(k). This is because you must start from a blank slate with gathering evidence to prove that all safety and efficacy requirements are met for De Novo, whereas a 510(k) submission allows for previously published data of a predicate device to be used for proving substantial equivalence.
However, in another sense, your company may see De Novo as the simpler option over a 510(k). You don’t have any burden to prove substantial equivalence and instead can craft your submission based on a robust risk mitigation strategy. This is made much easier if you have kept up-to-date with your QMS and kept meticulous records of your design and risk management activities.
Section 3.2 of the aforementioned FDA guidance outlines two mechanisms for interacting with FDA for a De Novo submission.
The first mechanism for interacting with FDA is through a Pre-submission. This is not compulsory but it is highlighted as a useful way to obtain early feedback from FDA. It can provide you with a preliminary perspective on the regulatory controls needed to prove the safety and efficacy of your device.
FDA suggests some questions to consider asking if engaging in the pre-submission process:
Based on the device description, its intended use/indications for use, and/or technological characteristics, and information on the search performed for legally marketed devices, does the FDA believe the device is eligible for De Novo classification?
Are there other risks, in addition to those identified in the Pre-Sub, given the indications for use for the device?
If applicable, are there controls that should be considered to provide a reasonable assurance of safety and effectiveness for the device?
Are the non-clinical study protocols sufficient to allow the collection of data from which conclusions about device safety and/or effectiveness can be drawn? For example:
Is the identified level of concern the appropriate level of concern for the device software?
What, if any, additional biocompatibility and/or sterility testing would be appropriate?
If clinical data is needed, are the proposed study design and selected control group appropriate?
The second mechanism is the actual De Novo submission request. FDA says this may be done either with or without a previous 510(k) submission. It notes:
The success of a De Novo request that is filed without a Pre- Sub will depend more heavily on how well you search for a potential predicate device, identify the risks to health and special controls (if applicable), and provide adequate valid scientific evidence to support granting the De Novo request.
If you’re not sure about which regulatory pathway you need to take, we strongly suggest getting in touch with a regulatory consultant first. You can run into considerable costs and time delays if you have to undergo the submission process more than once.
When you assess which pathway will be the best route for you to take in bringing your device to market, it’s important to understand the ins and outs of each. As mentioned previously, you can lose time and money, and potentially your competitive advantage if you go too far in pursuing a pathway that is the wrong fit for your device.
One way you can leverage De Novo as a competitive advantage in your regulatory plan is to make the case for one classification over another in your product submission. This can be a strategic move for your company. Any competitor down the line with a substantially equivalent device won’t be able to use the De Novo pathway.
You could argue that the device should be determined as Class I and present all necessary evidence to support your claim. This approach would greatly reduce your own time to market and lower your regulatory burden. But keep in mind, whatever case you make that is granted by FDA, you will pass along those same advantages to future competitors of your product.
On the other hand, making the case for your device to be Class II will set a higher standard for any future competitors. They won’t be cut corners in the submission process to accelerate their time to market, putting you at a longer term advantage.
There is one final mechanism worth mentioning whereby you can communicate with the FDA early and go into the De Novo submission process with a previously agreed upon determination of device class type.
FDA’s 513(g) submission involves a “request for classification” that allows manufacturers to solicit a predetermined classification of their device from FDA. Just note, there are additional fees for 513(g) submissions that will apply, so make sure you budget accordingly during your regulatory strategy planning.
Whichever regulatory pathway you use to bring your medical device to market, you are required to prove to FDA as to why it should be legally sold in the U.S. market. De Novo has a strong requirement associated with it where manufacturers must demonstrate that all possible risks have been considered and either mitigated or eliminated in order for FDA to grant the De Novo request.
One of the most effective ways to put yourself in the best possible position for your device to be granted is to keep robust records of every design and development activity, from ideation to design to validation of your device. The best QMS solutions are medical device specific with built-in controls that simplify and accelerate the entire go-to-market process.
Greenlight Guru is the only QMS software built exclusively for medical devices. Everything from risk management, to design controls, to document management is managed seamlessly in a safe and secure quality ecosystem, helping you achieve the desired outcomes of your De Novo submission and ensure the success of your medical device once it’s on the market. Get your free demo of our QMS software today.
Looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software
Tom Rish is a Medical Device Guru at Greenlight Guru who works with customers to utilize their QMS software to build safer products on expedited timelines. He is a Biomedical Engineer who began his career developing implant and instrument systems in the orthopedic industry. He enjoys helping customers successfully...