Frame the novel device
Clarify the technology, intended use, patient population, regulatory context, and key uncertainty FDA must evaluate.
Book a Scoping Call FDA De Novo Requests
De Novo Writing Services for Medical Devices
FDA De Novo writing support for novel medical devices, including benefit risk narratives, classification rationale, special controls, and clinical evidence.
The IMTS perspective
Evidence that stands up to scrutiny.
A De Novo request must establish a reasonable assurance of safety and effectiveness for a novel device while supporting an appropriate classification and risk control framework. IMTS develops evidence based narratives that help teams present this logic clearly.
Novel devices often require the submission to define the regulatory story as well as document it. The intended use, risks, mitigations, performance evidence, clinical data, and proposed special controls must work together without gaps or contradictions.
Scope of support
What we can deliver.
- 01De Novo request content
- 02Classification and regulatory rationale
- 03Benefit risk narratives
- 04Clinical evidence and literature summaries
- 05Proposed special controls and response support
How we work
A focused path from source evidence to final document.
Connect risks and evidence
Build a traceable narrative linking identified risks, mitigations, performance testing, and clinical support.
Support the review pathway
Coordinate cross functional content and help prepare clear responses as FDA questions refine the classification case.
Start a conversation
Bring us the document that needs to move forward.
We will help define the scope, source materials, review process, and practical next step.
Book a Scoping Call