There Is No Predicate. You Are the Precedent.
De Novo strategy for novel devices — the risk-based classification request that creates a new device type, writes its special controls, and puts your product first in the lineage.
The Facts That Frame Every De Novo.
A De Novo is not a consolation prize for a failed 510(k). Run deliberately, it is a strategic instrument.
What a granted De Novo creates: a new classification with general — and usually special — controls, for a novel device whose risks don’t warrant Class III.
The MDUFA review goal for a De Novo request — FDA days, on a submission that must carry classification logic and supporting evidence a 510(k) never needs.
The 2021 final rule that gave De Novo its own procedural regulation — content requirements, timelines, and grounds for declining, all in writing.
Automatic Class III Is the Default. De Novo Is the Correction.
A device with no predicate is Class III by statute — PMA territory — regardless of how modest its risks are. The De Novo request corrects that default: it asks FDA to classify the device on its actual risk profile, with general and special controls doing the work a full premarket approval would otherwise do.
The submission is therefore a different intellectual product than a 510(k). You are not comparing — you are characterizing: every probable risk named, every mitigation mapped to a control, and the evidence sized to prove the controls suffice. Reasonable assurance, argued from first principles.
The heart of a De Novo is the risk-to-control map — the table FDA turns into the special controls for the new device type.
You Are Writing the Rules Your Competitors Will Follow.
A granted De Novo doesn’t just clear your device. It creates a classification — and a market structure.
Your device is granted
FDA establishes a new classification regulation, assigns a product code, and publishes the special controls — drawn substantially from the mitigations you proposed and the evidence you supplied.
The controls carry your fingerprints
Testing expectations, labeling limits, design constraints — the special controls encode your risk analysis. Where you set the bar thoughtfully, you set it for everyone who follows.
The next entrant files a 510(k) — against you
Your granted device becomes the predicate for the device type. Competitors reach the market by demonstrating equivalence to your product, against controls you effectively drafted.
Which is why the strategy matters
A De Novo written narrowly protects nothing and invites a broader competitor filing; written carelessly, it saddles your own second generation. We draft it as the market-shaping document it is.
Six Disciplines That Carry a De Novo.
From the pathway decision itself to the special controls you will live under for a decade.
Pathway Confirmation
The disciplined predicate search first — a De Novo filed when a legitimate predicate existed wastes a year, and a 510(k) forced onto a novel device wastes two.
Pre-Submission Dialogue
De Novo programs live and die on early FDA alignment: the classification rationale, the evidence bar, and the clinical question tested in a Pre-Sub before the spend.
Risk-to-Control Architecture
The complete probable-risk inventory mapped to mitigations — the analysis FDA converts into the published special controls.
Evidence Program Design
Bench, biocompatibility, software, human factors, and clinical data sized to prove the controls suffice — reasonable assurance without PMA-scale spend.
The Request Itself
A submission built to 21 CFR 860 subpart D: classification recommendation, risk analysis, control map, and data — organized the way the reviewer must read it.
Precedent Strategy
Special controls drafted with the second generation and the second entrant in mind — the part of a De Novo most teams discover in hindsight.
With no predicate to lean on, the bench program establishes performance from first principles — the evidence plan is the strategy.
More Than a 510(k). Far Less Than a PMA — If You Aim It.
The recurring De Novo failure is evidence scoped by fear: teams run PMA-scale programs because no one told them where the bar sat. The bar is knowable — it is set by your own risk analysis, and FDA will discuss it. A Pre-Sub that asks the clinical-evidence question directly is the highest-leverage meeting in the program.
Where clinical data is needed, the study is usually targeted — performance against a defined endpoint, not outcomes at scale. We design it with the IDE mechanics and the eventual special controls in view, so one study serves both the grant and the label.
Six Failure Modes We Are Brought In to Prevent.
Most are strategy errors made before the request was drafted.
The predicate that was actually there
A De Novo filed on an incomplete predicate search — declined with a pointer to the 510(k) pathway, a year into the program.
Risk inventory with holes
Probable risks the request never named, surfaced by the review division — each one now a deficiency instead of a control you proposed on your terms.
Evidence scoped by fear
A PMA-sized clinical program for a Class II risk profile — two years answering a question FDA would have scoped in a meeting.
The classification argument left implicit
Data presented without the logic — why Class II, why these controls suffice — leaving the reviewer to build your argument or decline it.
Special controls drafted carelessly
Controls that hard-code one design choice — and bind your own next version while your competitor designs around the constraint you wrote.
Intended use drafted for the demo
An indication statement written around what the prototype does best instead of the clinical claim the evidence can carry — renegotiated at full price in review.
Leadership for Devices That Don’t Fit the Boxes.
Our leads have taken novel devices through classification arguments, Pre-Sub negotiations, and evidence programs built from first principles.
“A De Novo is the one submission where you get to write the rules. Most teams treat that as a burden. It is the most leverage FDA will ever hand you.”
The discipline we bring to first-of-kind devices.
Building Something With No Predicate? Decide the Pathway on Evidence, Not Hope.
A senior lead can pressure-test the predicate landscape and the classification argument before you commit the program to either pathway.
Senior-led. Embedded in your team. No junior hand-offs.