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FDA De Novo Submission Services for Novel Medical Devices
If you have a novel medical device with no suitable predicate and a low-to-moderate risk profile, the FDA De Novo submission process might be the most strategic route for market entry. At Elexes, our team of FDA regulatory experts helps manufacturers successfully navigate the FDA De Novo pathway, ensuring devices are classified correctly and reach the market without delays.
What Is a De Novo Submission and When Is It Required?
The De Novo Submission process is a risk-based classification option for novel medical devices for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but which have no legally marketed predicate. It offers an alternative to the 510(k) process, allowing a brand-new device type to be classified as Class I or II.
If your device has previously received a Not Substantially Equivalent (NSE) determination, or you are proactively avoiding the 510(k) route, a De Novo classification request might be appropriate.
Who Should Use the De Novo FDA Pathway?
A De Novo submission is ideal for manufacturers who:
⦿ Have developed a novel device with no comparable device already on the U.S. market
⦿ Can demonstrate safety and effectiveness with non-clinical or clinical data
⦿ Need a regulatory strategy that sets a foundation for future market growth
Common devices eligible for De Novo include:
⦿ AI/ML-based software (SaMD)
⦿ Wearables or connected devices
⦿ Diagnostics with new analytes
⦿ First-time therapeutic technologies
Is a De Novo Submission Right for You?
⦿ Your device is novel and has no legally marketed predicate
⦿ The device is low to moderate risk
⦿ You have supportive testing or clinical evidence
⦿ You’re ready to establish a new product classification
Step-by-Step: FDA De Novo Submission Process
At Elexes, we provide end-to-end De Novo support, with services that include:
Regulatory Strategy & Pre-Submission
⦿ Evaluate De Novo suitability
⦿ Prepare and submit Q-Sub meeting requests
⦿ Attend and guide FDA pre-submission meetings
Compilation of Submission Package
⦿ Prepare device description, labeling, and use case analysis
⦿ Develop testing protocols and validation reports
⦿ Draft risk/benefit analyses and justification for classification
Submission & Review Support
⦿ File De Novo request through eSTAR or other appropriate FDA systems
⦿ Respond to FDA deficiency letters
⦿ Communicate with reviewers throughout the review cycle
Post-Approval Services
⦿ Device listing
⦿ Support for future 510(k)s
⦿ Market launch readiness consulting
How Elexes Helps with De Novo Classification
With extensive experience across Class I, II, and novel devices, Elexes provides comprehensive De Novo submission services, including:
Pre-Submission Strategy & FDA Interaction
⦿ Determine De Novo suitability
⦿ Draft and submit Pre-Submission (Q-sub) to the FDA
⦿ Facilitate meetings and responses to FDA questions
De Novo Request Compilation
⦿ Prepare required elements: labeling, test protocols, summaries, clinical/performance data
⦿ Risk and benefit analysis to demonstrate reasonable assurance
⦿ Device description, intended use, comparison with similar marketed devices
Submission & Review Support
⦿ Submit De Novo request through the appropriate FDA channels
⦿ Respond to deficiencies and provide clarifications
⦿ Liaise with FDA reviewers during the decision-making process
Post-Approval Support
⦿ Labeling updates, market launch readiness
⦿ Device listing, compliance documentation
⦿ Future 510(k) facilitation for similar devices
Benefits of Partnering with Elexes as a De Novo Consultant
Hiring the right consultant can make or break your De Novo submission. With the complex regulatory nuances, evolving FDA expectations, and the high stakes of launching a first-of-its-kind medical device, you need a partner who offers more than just paperwork support. At Elexes, we serve as your De Novo regulatory strategy partner, guiding you from concept to FDA approval and beyond.
Elexes supported a first-of-its-kind wearable therapeutic device through a De Novo submission, achieving approval within the projected timeline and enabling rapid market launch.
Proven Track Record with FDA De Novo Submissions
We have successfully supported numerous clients in securing De Novo classifications, especially for digital health technologies, diagnostic devices, and breakthrough innovations. Our deep familiarity with both traditional and modern FDA expectations allows us to tailor every submission with precision, reducing the risk of review delays and rejections.
Custom-Tailored Regulatory Strategy
No two De Novo devices are the same, and your submission shouldn’t be either. We don’t use cookie-cutter templates—instead, we assess your device’s unique features, risk profile, and intended use to build a regulatory roadmap that aligns with your product strategy, development timeline, and go-to-market goals.
Strategic Advantage for Future 510(k) Submissions
Once your device is cleared via the De Novo pathway, it can serve as a predicate for future 510(k)s. Elexes positions your submission in a way that not only satisfies FDA requirements today, but also paves the way for future device iterations, product extensions, and competitive advantage.
Expertise in Navigating FDA Communications
Whether it’s preparing a De Novo Q-Submission (Pre-Submission) or responding to FDA deficiency letters, our team speaks the FDA’s language. We know what reviewers look for and how to craft responses that are clear, evidence-based, and persuasive. Our experts also attend and support FDA meetings, so you’re never navigating these interactions alone.
Multidisciplinary Team for End-to-End Support
Elexes brings together regulatory scientists, engineers, clinicians, and quality experts to ensure your submission is technically sound and regulatory-ready. From biocompatibility plans and risk management files to software documentation and clinical evaluations, we manage every component of your submission to FDA standards.
Trusted by Startups and Fortune 500s Alike
Whether you’re a lean startup or a global enterprise, our team adapts to your internal workflows and resources. Our flexible, collaborative model has helped clients across the U.S., EU, and APAC meet aggressive timelines and budget constraints without compromising on compliance or quality.
Transparent Process & Clear Deliverables
From day one, you’ll know what to expect. We provide a detailed project timeline, deliverable checklist, and regular updates throughout the submission lifecycle. You’ll always know where your project stands, what the next steps are, and how to prepare for each milestone.
Let Elexes Be Your Regulatory Advantage
De Novo submissions require more than regulatory know-how—they demand foresight, adaptability, and flawless execution. With Elexes, you gain a trusted De Novo submissions consultant who is fully invested in your product’s success, compliance, and long-term market sustainability.
Understanding the De Novo Pathway at a Glance
Compare your options and know what to expect with visual insights into key differences and timelines.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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Tom Birney
CEO Masterlink, Arizona
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Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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