How long does a De Novo take?

FDA's MDUFA goal is 150 days for the review clock, but total time from submission to grant commonly runs 6 to 12 months. Direct De Novo submissions (without a prior 510(k) NSE letter) are now the standard path.

Does a De Novo require clinical data?

Sometimes. Clinical evidence is required when non-clinical testing cannot establish safety and effectiveness for the proposed indications. AI and diagnostic De Novos usually include a pivotal validation study.

Can others use my De Novo as a predicate?

Yes. Once granted, the De Novo creates a classification order that any subsequent 510(k) can cite as a predicate, subject to the special controls FDA established for the device type.

All terms

RegulatoryRegulated Pathways Quality System Global MarketsDe Novo

De Novo Classification Request

Pathway to classify novel low- to moderate-risk devices that lack a predicate.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

What this means in practice

Granting a De Novo creates a new device classification (Class I or Class II with special controls) and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category. It is intended for novel devices where risk is low to moderate but no legally marketed predicate exists.

Examples

The first cleared AI-based diabetic retinopathy screening software, which established a new device type and enabled subsequent 510(k) submissions.
A novel low-risk digital therapeutic classified into a newly created Class II product code with special controls.

Use cases

1 scenario

First-of-kind continuous glucose-trend wearable

Regulatory strategist

A wearable measures interstitial glucose trends but doesn't fit any existing product code. The sponsor receives a Not Substantially Equivalent decision on a 510(k), then files a De Novo with risk-based special controls.

OutcomeFDA grants De Novo classification as Class II and creates a new product code, which becomes a predicate for future entrants.

Common pitfalls

•Filing a De Novo when a plausible predicate exists. FDA may redirect the submission to a 510(k), losing months.
•Underestimating the special controls FDA may impose, which become binding on the applicant and future 510(k) followers.
•Skipping a Pre-Submission (Q-Sub) meeting to confirm De Novo is the correct pathway.

Frequently asked questions

De Novo fits novel low- to moderate-risk devices with no legally marketed predicate. If a predicate exists, use 510(k). If the device is high risk (Class III), use PMA.

Cross-references

Often confused with

Distinct concept frequently mistaken for this one.

510(k) Premarket Notification(510(k))
De Novo is for novel devices lacking a predicate.

Shared paths + category

Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

510(k) FundamentalsDe Novo & Breakthrough Pathways

Regulatory

Premarket Approval(PMA)

FDA's most stringent device marketing application, required for high-risk Class III devices.

De Novo & Breakthrough Pathways · adjacentFounder & Investor Primer · adjacent

Regulatory

Predicate Device

A legally marketed device used as the comparator in a 510(k) submission.

510(k) FundamentalsDe Novo & Breakthrough Pathways

Regulatory

Substantial Equivalence(SE)

The legal standard a 510(k) device must meet versus a predicate.

510(k) FundamentalsDe Novo & Breakthrough Pathways

Regulatory

Breakthrough Device Designation(BDD)

FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.

De Novo & Breakthrough Pathways · adjacentFounder & Investor Primer · adjacent

Regulatory

Indications for Use(IFU (statement))

Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.

510(k) FundamentalsDe Novo & Breakthrough Pathways

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Primary references

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Definition

What this means in practice

Examples

Use cases

First-of-kind continuous glucose-trend wearable

Frequently asked questions

Often confused with

Related terms

Latest in MedTech

Primary references