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FDA De Novo Application Submission Support for Medical Devices and IVDs
Why Companies Choose NAMSA
100+
FDA Pre-Submission Meetings Managed Each Year
3,000+
Medical Device and IVD Manufacturers Supported Each Year
13
Consultants with Previous US FDA or EU Notified Body Experience
Benefit Oriented Deep Expertise in FDA Compliance
Unlike many other markets, the US FDA regulatory pathway for medical devices and IVDs is based on a “predicate” system. This means that the type of application pursued for new devices depends on whether they can be deemed substantially equivalent to a similar device already cleared by FDA. What happens if you have invented a novel new technology? One option that may be appropriate is the De Novo classification pathway. As a leading medical device CRO, NAMSA can help you gather the data needed and prepare the application required to gain De Novo classification.
Is the De Novo Process Right For You?
- Moderate risk devices (not high risk; rarely low risk)
- No existing predicate device cleared by FDA
- No matching product code in FDA database
NAMSA Can Help You Secure De Novo Classification for Your Medical Device
A novel medical device or IVD without any established predicate device is automatically considered a Class 3 device by the FDA. This means that FDA considers it to be high risk until proven otherwise. Most Class III devices must go through the rigorous, costly and time consuming Premarket Approval (PMA) process. However, just because a device incorporates novel technology does not mean it poses a high risk to patients or users. That’s why the De Novo process was created.
Less than 2% of all medical devices go through the De Novo process each year and most devices are approved by FDA in 12-14 months. FDA’s decision to grant De Novo approval is highly dependent on your ability to produce scientifically sound data to support your claims and demonstrate safety and efficacy. We can help guide you through the process.
Partner with a Company That Can Produce the Data FDA Needs
One of the advantages of working with NAMSA on your De Novo application is that – unlike most regulatory consulting firms – we also offer extremely deep expertise in medical device preclinical research, testing and clinical studies. Because your device or IVD incorporates novel technology and cannot be compared to existing devices already cleared by FDA, determining which relevant data to collect, and doing so, may be more difficult. Due to our past experience with thousands of different devices and IVDs, NAMSA experts can guide you to collect the data FDA wants to see in order to demonstrate that your device meets FDA general safety and effectiveness controls. This increases the odds of FDA accepting your De Novo request and moving into the “substantive review” phase. NAMSA has clinical and regulatory expertise in many areas, especially the following:
- Anesthesiology and Respiratory
- Cardiovascular
- Dental
- Ear, Nose, & Throat
- Gastroenterology & Urology
- In Vitro Diagnostics
- Neurology
- Oncology
- Ophthalmic
- Orthopedic
- And More
Ask us for details on our experience in each area.
Get De Novo Approval Faster with NAMSA’s APEX PROGRAM
NAMSA knows that small and emerging growth companies have a need for speed and keeping costs under control. If getting your product to market as fast as possible is essential, consider our APEX PROGRAM. We will pair you with a single senior NAMSA consultant who will guide and speed you through all aspects of preclinical and clinical research, testing, De Novo application preparation, and ultimately, regulatory submission.
Meet Our FDA Experts
Meet the team ready to put their expertise to work for you.
Frequently Asked Questions About the De Novo Process
What is a De Novo application?
When a medical device manufacturer creates a truly novel medical technology that has no predicate (already cleared) device, the FDA automatically classifies it as a Class 3 high risk device. Most novel technologies do not warrant Class III designation and are typically Class II devices. Manufacturers can pursue a De Novo classifcation which provides a pathway to market by making the case that general/special controls provide reasonable assurance of safety and effectiveness.
What classification is assigned to De Novo devices?
De Novo devices can be Class 1 or Class 2. However, of the 79 medical devices and IVDs cleared through the De Novo process between mid 2022 and mid 2024, all were given a Class 2 designation by the FDA.
What is the difference between De Novo and 510(k)?
The requirements are similar in terms of the type of data needed to support safety and efficacy, however there are a few key differences to consider. In a 510(k) submission you must show substantial equivalence to a predicate device and in a De Novo submission you do not. In a De Novo submission you must explain what general and special controls provide a reasonable assurance for safety and effectiveness. If a De Novo request is granted, then similar devices can follow the normal 510(k) process, using the original De Novo device as their predicate. The time it take from submission to a FDA decision can be months longer for the De Novo review as compared to a 510(k) review.
How long does the De Novo pathway take?
NAMSA conducted an analysis of all De Novo applications submitted between July 1, 2022 and June 30, 2024. During that period, 79 medical devices and IVDs were approved via the FDA’s De Novo process. The average time between submission and decision by the FDA was 12-14 months.
Other FDA Services That May Interest You
FDA 510(k) Consultants
FDA PMA Consulting
