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Expert FDA De-Novo Submission Services

For over a decade, Freyr has been a trusted partner for the FDA De-Novo submission services. Our team of experienced consultants specializes in understanding your FDA De-Novo classification request and guiding you through the De-Novo classification process  in order to obtain FDA clearance for novel medical devices. With our comprehensive understanding of the Regulatory landscape, we ensure a seamless De-Novo submission experience, maximizing your chances for a successful device classification.

Book a meeting with our De-Novo submission experts


Streamlined FDA De Novo Submission Services

Our streamlined FDA De Novo submission services are designed to simplify the complex classification process for novel medical devices. We provide comprehensive support, guiding you through every step of the submission process. With our in-depth knowledge on the FDA regulations and requirements, we ensure that your submission meets all the necessary criteria for a successful De Novo classification request.


Expert Guidance on the FDA De Novo Classification

Obtaining the FDA De Novo classification is a critical step for novel medical devices. Our team of Regulatory experts specializes in providing guidance on the De Novo classification process. We assist you in preparing the necessary documentation, conducting thorough device testing, and navigating the Regulatory requirements. As a trusted Regulatory partner for a decade, we will support and  guide you through the intricacies of the FDA De Novo classification.


Comprehensive De Novo Submission Support

We offer comprehensive De Novo submission support to streamline the process for you. Our team of Regulatory experts will assist you in compiling the required documentation, conducting risk assessments, and preparing a comprehensive submission package that meets the FDA standards. We ensure that your submission is complete, accurate, and aligns with the De Novo Regulatory pathway.


Navigating the De Novo Classification Process

The De Novo classification process can be complex, but with our guidance, you can navigate it with confidence. Our team of Regulatory experts is well-versed in the De Novo Regulatory pathway and will provide you with the necessary support at every stage. We help you understand the FDA's expectations, assist in addressing any queries or concerns, and ensure that your submission is in compliance with the FDA regulations.

MDUFA User Fees:

Financial Year


Standard Fee

Small Business Fee*

FY 2023

October 1st,2022 to September 30th 2023

$ 132,464

$ 33,116

Freyr Expertise and Advantages


Freyr Expertise

  • End-to-End De-Novo Registration
  • Pre-Submission / Q-Submission Meeting Request
  • Evaluation and Identification of Applicable Special Controls
  • Risk-Benefit Determination
  • Compilation of De-Novo Submission Package
  • Publishing and E-copy Creation for Pre-Submission and De-Novo Request Application
  • Liasing Services

 Insightful Resources for Your De Novo Submission Journey

Kickstart your De Novo submission process.