Eligibility and landscape
Classification search, predicate challenge, 513(g) or Q-Submission considerations and documented rationale for the proposed De Novo route.
FDA De Novo Classification Request
FDA De Novo submission support for novel devices.
We help teams assess De Novo eligibility, define the device type and risks, plan the evidence, propose proportionate special controls and assemble the request in FDA eSTAR.
Selected clients
Healthcare teams we have supported
Scope and deliverables
De Novo work included in the service.
The pathway must be justified product by product. De Novo is not a shortcut around evidence and is not appropriate for high-risk devices requiring PMA.
Device type and classification
Proposed device type, identification, class, regulation language, product-code concepts and scope boundaries.
Risk and special-controls framework
Risk-to-health analysis, mitigations, proposed special controls and explanation of why general and special controls provide reasonable assurance.
Benefit-risk and evidence plan
Benefits, risks, uncertainty, patient perspective where relevant, nonclinical and clinical evidence mapped to each regulatory question.
eSTAR request preparation
Device description, labeling, software, cybersecurity, human factors, performance and administrative content assembled in the current template.
Review and deficiency support
Acceptance preparation, interactive review, response planning and controlled amendments through grant or decline.
Ways to work together
Choose the support your team needs.
De Novo strategy and Pre-Sub
Resolve classification, evidence and special-control questions with a focused FDA feedback package before major spend.
Complete request
Coordinate the regulatory narrative and agreed technical workstreams through eSTAR submission and review.
Independent challenge
Review an existing plan or request for predicate risk, evidence gaps, control sufficiency and internal consistency.
How it works
Our process.
- 1
Test eligibility
Assess novelty, risk, predicate landscape and alternative pathways.
- 2
Define controls
Link risks to mitigations, evidence and proposed special controls.
- 3
Build the request
Generate and integrate technical, clinical, software and labeling evidence in eSTAR.
- 4
Navigate review
Support FDA questions, amendments and final classification requirements.
Regulations, standards and guidance considered
FD&C Act §513(f)(2)21 CFR Part 860 Subpart DFDA De Novo GuidanceFDA eSTARFDA QMSRISO 14971IEC 62304IEC 62366-1
Frequently asked questions
Questions teams ask before they begin.
When is De Novo appropriate?+
It is intended for certain novel device types for which general controls, or general and special controls, can provide reasonable assurance of safety and effectiveness and for which there is no legally marketed predicate supporting a 510(k).
Is a prior 510(k) NSE decision required?+
No. A sponsor may submit a direct De Novo request without first receiving a not-substantially-equivalent decision, provided the statutory criteria and request requirements are met.
What are special controls?+
Special controls are device-specific regulatory requirements for class II devices, potentially including performance standards, testing, labeling, patient monitoring or post-market measures. Proposed controls should be precise, verifiable and tied to identified risks.
Does De Novo require clinical evidence?+
Not automatically, but novel intended uses or technologies often create questions that cannot be answered by nonclinical testing alone. The decision should follow from the benefit-risk and uncertainty analysis, ideally informed by early FDA feedback.
How is an FDA-granted De Novo used later?+
A grant creates a new class I or II device type and classification regulation. When applicable, the granted device may then serve as a predicate for future 510(k)s.
Can a grant or timeline be guaranteed?+
No. FDA may disagree with eligibility, classification, controls or evidence and can request additional information or decline the request. Timelines also depend on sponsor response periods.
Start with the product you have