Biomedix De Novo Pathway Submission Series
Video 1 – Introduction to the De Novo Pathway
An overview of the FDA’s De Novo pathway—when it applies, why it exists, and how it supports innovative devices without valid predicates.
Video 2 – Eligibility and Submission Criteria
How to determine De Novo eligibility, assess predicate absence, and avoid early decision-making pitfalls when choosing the correct FDA pathway.
Video 3 – Preparing Your De Novo Submission File
A guide to structuring a complete De Novo file—technical, clinical, and risk documentation—with tips for clarity and avoiding deficiency letters.
Video 4 – Understanding the FDA Review Process
A step-by-step look at the De Novo review process, including RTA, Substantive Review, AI letters, and how to navigate reviewer communication effectively.
Video 5 – Post-Market Responsibilities
Covers post-clearance obligations including surveillance, reporting, special controls, and integrating De Novo requirements into your QMS.
Video 6 – Standards & References
How to use FDA-recognized standards in a De Novo submission to streamline testing, support claims, and strengthen the overall submission strategy.
Video 7 – Case Studies & Lessons Learned
Real-world case studies—AI diagnostics, neuromodulation, and wound healing— highlighting key challenges and strategies that shaped successful De Novo reviews.
Video 8 – Summary & Key Resources
A concise wrap-up of the entire De Novo pathway—planning, eSTAR use, standards, FDA engagement, and tools to support future submissions.