FDA · De Novo Request · Novel Class I/II Devices
US De Novo Request · Strategy, Evidence & eSTAR
For novel, low-to-moderate-risk devices with no suitable predicate, a De Novo request can create a new Class I/II classification—if your benefit–risk story and proposed controls are clear. We provide a consulting and documentation service that defines your De Novo strategy, proposes special controls, organizes clinical and nonclinical evidence, and packages everything in FDA’s eSTAR template. From October 1, 2025, De Novo submissions must use eSTAR unless exempted.
Fit-for-purpose pathway
Benefit–risk clarity
Transparent special controls
eSTAR-compliant structure
Why De Novo & eSTAR Matter Now
Choosing the right U.S. pathway and structuring the file correctly are critical for novel devices without a predicate.
- Right pathway for novel devices: De Novo creates a new Class I or II classification when there is no predicate and general and/or special controls can provide reasonable assurance of safety and effectiveness.
- eSTAR is mandatory for De Novo: From October 1, 2025, De Novo requests must use FDA’s eSTAR electronic template, unless specifically exempted. Structuring content to match eSTAR from the start improves intake and routing.
- Acceptance review applies: FDA uses an Acceptance Checklist (RTA-style) to decide whether a De Novo file is administratively complete. Incomplete submissions can be refused before substantive review.
- Benefit–risk clarity: De Novo decisions weigh benefits, risks, and mitigations. Your narrative must link risks to controls and show how evidence supports the proposed classification and special controls.
We focus on the three big risks—wrong route, weak SE story, and RTA issues—and address them in a single, eSTAR-ready package.
When This De Novo Service Is a Good Fit
We support teams who need a structured, defensible De Novo route—not just a formatted template.
- No suitable predicate exists, and a 510(k) path is not appropriate.
- You want to avoid a PMA by demonstrating that risks can be controlled with general and special controls.
- You need to define and justify special controls for a new device type.
- This is your first De Novo, or your first time using eSTAR for a De Novo submission.
- You have evidence, but it is fragmented across engineering, clinical, and risk teams and needs a single benefit–risk story.
What You Will Receive
Deliverables are designed around four core outcomes: a clear strategy, transparent controls, mapped evidence, and an eSTAR-ready file.
De Novo Strategy Memo
- Intended use and indications for use, expressed in De Novo-appropriate language.
- Eligibility rationale: why De Novo is appropriate vs. 510(k) and PMA.
- Initial benefit–risk summary: target population, key benefits, key risks, and overall rationale.
- Recommendation for De Novo pathway, including whether to seek early alignment via a Q-Submission.
Risk & Mitigations Register With Proposed Special Controls
- Structured list of device risks and failure modes.
- Mapping from each risk to general controls and proposed special controls (e.g., performance testing, labeling statements, post-market activities).
- Justification for how each control contributes to safety and effectiveness.
- A view that can be reused in risk management documentation and discussions with FDA.
- Intended use and indications.
- Technological characteristics (design, materials, energy source, key features).
- Performance characteristics where relevant.
Evidence Map + Gap Log
- Map of nonclinical and clinical evidence against risks, endpoints, claims, and proposed special controls.
- Identification of gaps or weakly supported aspects, plus suggested actions (additional analyses, clarifications, or studies where appropriate).
- Linkage between protocols, reports, and key tables/figures to make reviewer navigation easier.
eSTAR Package & Acceptance-Readiness
- Drafted narrative, summaries, and tables placed into the structure expected by FDA’s eSTAR template for De Novo.
- Internal acceptance pre-check against FDA’s De Novo Acceptance Checklist to reduce refusal-to-accept risk.
- Clear instructions for your regulatory owner/U.S. Agent on how the eSTAR file is organized and where key items are located.
How Our De Novo Service Works
We move from basic eligibility and evidence inventory to an eSTAR-ready, acceptance-aware De Novo package.
Discovery
- Confirm intended use, indications, technology description, and available evidence. Clarify risk profile, current standards, and target timelines.
Eligibility & Pathway
- Analyze why De Novo is appropriate vs. 510(k) or PMA, and outline an initial benefit–risk view and concept for special controls. If helpful, we identify topics to take to FDA in a Q-Submission.
Evidence & Controls
- Build a risk → mitigation register, link each risk to general and proposed special controls, and summarize nonclinical and clinical data that support those controls. Produce an evidence map and gap log with concrete follow-up actions.
Documentation & eSTAR Assembly
- Draft the core De Novo narrative, summaries, and tables; assemble them into FDA’s eSTAR template; and run an acceptance-style pre-check. Deliver an eSTAR-ready package your regulatory owner can submit.
Scope & Boundaries
We keep the scope focused on strategy, evidence organization, and documentation—no hidden promises.
- In Scope
- Strategy for choosing De Novo vs. other U.S. pathways.
- Development of a De Novo benefit–risk narrative and proposed special controls.
- Risk–mitigation register and mapping of evidence to risks, claims, and controls.
- Drafting and structuring content for the De Novo request in eSTAR format.
- Internal acceptance-style checks and guidance for submission packaging.
- Out of Scope
- Laboratory testing or running clinical studies.
- Authoring your official labeling (we may review drafts for alignment only).
- Acting as your regulatory owner or U.S. Agent, and directly submitting to FDA.
- Providing legal advice or representing you in enforcement actions.
Consulting and documentation only. We do not perform laboratory testing and do not author labels; clients contract labs and submit via their regulatory owner or U.S. Agent.
- Inputs We Will Request From You
- Intended use and indications for use (draft or working version).
- Device technology description and high-level manufacturing overview.
- Current risk management files and applicable standards.
- Nonclinical and clinical protocols and reports; available statistics plans and outputs.
- Any prior FDA interactions (e.g., 510(k) attempts, Q-Subs) relevant to the device.
- Draft labeling and Instructions for Use (for alignment, not authorship).
- Target De Novo submission date and internal milestones.
FREQUENTLY ASKED QUESTIONS
De Novo is appropriate when there is no legally marketed predicate device and the device’s risk can be adequately controlled using general controls and, where needed, special controls. If a suitable predicate exists, a 510(k) is usually the primary route.
Yes. For De Novo requests submitted on or after October 1, 2025, FDA requires use of the eSTAR template, unless a specific exemption applies.
It depends on the device’s risks and claims. Evidence must be sufficient to support the benefit–risk profile and the proposed special controls. For some devices, nonclinical evidence may be enough; others require clinical data.
No. The formal submission is made by your regulatory owner or U.S. Agent. We prepare the strategy, narrative, and eSTAR content so their submission is organized and ready for FDA intake.
Yes. As part of the strategy phase, we can identify key questions and draft materials you may want to bring to FDA in a Q-Submission to de-risk your De Novo before filing.
Build a De Novo Request With Clear Strategy, Evidence & eSTAR Structure
If your device has no predicate and you want a fit-for-purpose pathway instead of PMA, a De Novo request can create the right classification—if risks, controls, and evidence are presented clearly. We help you define the De Novo strategy, propose special controls, map evidence to risk, and assemble an eSTAR-compliant file that anticipates acceptance checks and supports a faster, clearer review.
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