Who this is for
Novel-device manufacturers where a suitable predicate may not exist and a risk-based De Novo classification could be relevant.
Medical Devices
FDA De Novo Pathway Assessment Support
ConformArc handles the initial enquiry and helps connect you with a relevant provider for this requirement. The selected provider confirms applicability, technical scope, deliverables, fees and timing. The following explains work that may be relevant to the project; it is not a fixed package supplied by ConformArc.
Typical work to discuss with a provider
- Feasibility and pathway review
- Risk-control and evidence-gap map
- Potential Pre-Submission question planning
- Testing and performance-evidence workstream coordination
- Submission-project coordination with appropriate regulatory specialists
Useful inputs for an initial review
- Device description
- Indications
- Design and risk information
- Predicate search notes
- Available studies and QMS status.
Scope and report acceptance. De Novo pathway assessment is coordinated with specialists; FDA decides whether to grant a request. Capability must be verified before treating this page as a live offer.
Role clarity. Enquiry support and specialist introductions. Testing, technical advice, certification and regulatory decisions remain with the responsible service providers and authorities.
ConformArc handles the initial enquiry and helps connect you with a relevant provider for this requirement. The selected provider confirms applicability, technical scope, deliverables, fees and timing. The following explains work that may be relevant to the project; it is not a fixed package supplied by ConformArc.
A novel low- to moderate-risk device without an appropriate predicate may warrant assessment of the FDA De Novo pathway. The route cannot be chosen from a marketing label alone. ConformArc can discuss an introduction to a provider that coordinates a specialist review of intended use, technology, classification history, risks, proposed controls and the evidence needed to support a request.
A useful early deliverable is a pathway decision memo that compares plausible alternatives, identifies missing performance and safety data, and sets out a submission work plan. Depending on the device, work may include bench, software, biological, electrical, usability or clinical evidence. Regulatory specialists should verify current FDA guidance and submission requirements. FDA decides whether to grant a De Novo request; ConformArc does not promise classification or market access.
Frequently asked questions
Is De Novo a fallback for every failed 510(k)?
No; eligibility and evidence need their own assessment.
Sources / further reading
Requirements can change. Confirm the current route and applicable edition for the specific product before starting the project.
Discuss this requirement
Share your product details for FDA De Novo Pathway Assessment Support. The form lists this service and closely related options only.