You’ve spent months, if not years, finetuning a concept you want to bring to market to improve the lives of patients.
Maybe you’re having trouble finding a substantially equivalent predicate device, so a 510(k) is out of the picture.
And your product isn’t Class III, so no need for a PMA.
Going De Novo could be the answer for you.
Let’s get a better look at the De Novo pathway with insight into what it is and how it works.
A De Novo submission is a pre-market submission type for novel moderate risk (or Class II) devices with no legally marketed predicate.
Before the introduction of the De Novo program, novel devices had two possible paths to get to market:
OR
However, neither of these options were ideal for low and moderate-risk, novel devices.
This changed with the implementation of De Novo in 1997 and is improved with the latest rule update in 2022.
We’ll discuss more of the Final Rule Update below.
Before you submit your De Novo application or engage in any Q-Sub meetings, it’s important to know your device’s risk assessment and its overall safety and effectiveness (via bench testing, preclinical testing, and clinical testing).
To qualify for De Novo, make sure your device meets the following requirements:
To start confirming these elements, a thorough regulatory review of currently marketed products should be conducted to determine those most similar to your product. Then, an analysis of the substantial equivalence of these products should be performed.
If no products are substantially equivalent but most similar products fall into Class I or II, you’ve likely addressed Bullet 1.
Further confirmation of your rationale can be obtained from a pre-submission meeting with FDA during which you can discuss your regulatory pathway. During this meeting with FDA, you may also discuss your testing, which will inform your special controls, and your benefit-risk assessment.
FDA will provide you feedback on these elements which you can then use to support a future De Novo submission.
There are two ways to go about filing a De Novo request.
Under this option, you would first file a 510(k). Then after receiving a not substantially equivalent determination, you will need to generate and file an entirely new submission.
This effectively means you will be pulling together two submissions—one 510(k) and one De Novo—and submitting both to FDA. Both will be subject to user fees, and the review clock restarts after the NSE.
Our advice is to stray away from this option, if possible, to avoid the unnecessary time, costs, and burden. One way to avoid filing an unnecessary 510(k) is to have a pre-submission meeting in which you can discuss your regulatory pathway.
You can learn more about pre-submissions here.
This path avoids the need for a 510(k) submission. If your device is, in fact, a De Novo device, then this pathway will be more efficient and cost-effective than Option 1.
Following this pathway, you will only need to generate one submission, pay one MDUFA user fee, and undergo one review (assuming you’ve got all your ducks in a row).
Similar to the above statement, a pre-submission meeting is still recommended even if you’re pretty confident that you are going to follow the De Novo pathway. In this pre-submission, you may confirm the pathway and your testing plans.
There are two different parts of the review process with the De Novo review request.
In 15 days, FDA will supply one of the following:
After the FDA accepts the De Novo request for review, Substantive Review begins.
During this time in the review process, the FDA may identify deficiencies in the submission.
For example, if your submission is missing testing information and data needed for the FDA to make their decision— this would be considered a deficiency.
At that point, you would have 180 days to submit additional information.
If you have supplied the appropriate and necessary information and the FDA determines your device to be safe and effective— you’ll be on the way to getting your De Novo granted.
In October of 2021, the FDA released what they called the “Final Rule” for De Novo.
This update cemented common practices that were not clearly defined in guidance documents but are now listed as accepted practices.
One of the biggest changes in the update is the acceptance checklist. Previously, the RTA checklist had two sections:
Appendix A – require and Appendix B – Recommended
With the latest update, almost all of the elements from both sections are now required. Some of the newly required elements include the classification summary and device labeling.
This change affects only a small number of De Novo requests. If the device has critical or novel manufacturing processes that could affect the safety and efficacy of the device, the FDA may inspect the facility for data integrity concerns and quality system regulation.
The FDA suggests discussing questions about whether a premarketing manufacturing inspection would be required and its scope in a pre-submission meeting.
Since De Novo is not a PMA, the FDA recommends using marketing language like “granted De Novo” or “granted marketing authorization” rather than “FDA approved.”
If you want a smooth experience without any unexpected surprises, rely on an experienced CRO that is familiar with the De Novo review and submission process and can guide you with success.
Contact Proxima CRO for all of your regulatory and clinical needs.
