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FDA De Novo Consulting Services
Have a groundbreaking medical device with no clear predicate? Our De Novo consulting services are designed to help you secure market entry with confidence. The De Novo pathway is a critical FDA process for novel Class I or II devices that don’t qualify under the 510(k) route. At Elexes, we help you navigate every step from pre-submission to approval, accelerating your product’s time to market while ensuring full compliance.
Understanding the FDA De Novo Classification Request
The De Novo pathway is the FDA’s solution for novel medical devices with no substantially equivalent (SE) predicate. It allows classification of low to moderate risk devices into Class I or II. This classification becomes the predicate for future 510(k) submissions.
When is De Novo Required?
If your 510(k) was rejected due to “Not Substantially Equivalent” or you already know there’s no existing predicate, De Novo is your best route.
Why Choose De Novo?
It gives first movers a unique advantage. You not only get FDA approval but also set a predicate for future competitors.
How is De Novo Different?
Unlike 510(k), De Novo demands robust evidence including clinical and non-clinical data for risk analysis, performance, and safety.
Our Proven De Novo Consulting Process
Why Choose Elexes as Your De Novo Consulting Partner?
⦿ Comprehensive Device Assessment: We determine if De Novo is the best pathway for your product.
⦿ FDA Pre-Submission Support: Strategize communication with FDA to avoid future delays.
⦿ Clinical Strategy & Study Design: Plan human or animal studies aligned with FDA expectations.
⦿ Risk-Based Documentation: Help with benefit-risk analysis, special controls, and labeling.
⦿ Complete De Novo Submission Preparation: From formatting to eSTAR requirements.
⦿ Regulatory Representation: Act as your US Agent and support during FDA review.
⦿ Post-Approval Compliance: We stay with you to ensure ongoing regulatory support.
Elexes Expertise in Action
De Novo Submission Support
⦿ Strategy for breakthrough software, combination products, and wearables
⦿ Customized submission planning and FDA liaison services
⦿ Clinical study alignment with ISO 14155 and FDA GCP guidelines
End-to-End Documentation
⦿ Pre-submission package, risk management, and labeling reviews
⦿ Support with De Novo request, benefit-risk narrative, and summary reports
⦿ Device description, intended use, and indications alignment
Cross-Functional Collaboration
⦿ In-house team of regulatory scientists, engineers, and clinicians
⦿ Experience with AI-based diagnostics, surgical devices, and mobile health apps
⦿ Seamless collaboration with legal, marketing, and clinical teams
Click here to download the full De Novo Submission Checklist
Be the First. Lead the Market.
With Elexes, you’re not just getting regulatory support, you’re setting the benchmark for future devices. Let us help you gain approval through the De Novo classification request and position your innovation for long-term success. Click here to know what our clients have to say about us.
Visualizing the De Novo Advantage
FAQs
Frequently Asked Questions!
The De Novo pathway is a regulatory route offered by the FDA for novel medical devices without a suitable predicate. It allows classification into Class I or II.
If no substantially equivalent device exists for your innovation, and your product poses low to moderate risk, a De Novo request is the appropriate route.
On average, the FDA review process for De Novo submissions takes 150 to 180 calendar days, depending on complexity and data requirements.
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!
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Tom Birney
CEO Masterlink, Arizona
“
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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